Recall events
/
Event 98918
Event summary
Timeline bucket April 30, 2026
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording SURGIFY MEDICAL OY
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
19 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 19
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
Z-2555-2026
Recall number Z-2555-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity 15 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2555-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46802]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532229; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[137]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 19
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Z-2556-2026
Recall number Z-2556-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2556-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17116]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532205; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[125]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 19
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Z-2557-2026
Recall number Z-2557-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2557-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5310]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532212; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[116]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 19
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Z-2558-2026
Recall number Z-2558-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity 112 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2558-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40174]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532076; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[92]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 19
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Z-2559-2026
Recall number Z-2559-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2559-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5312]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532281; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[115]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 19
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Z-2560-2026
Recall number Z-2560-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2560-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40180]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI06429811532069; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[141]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 19
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Z-2561-2026
Recall number Z-2561-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2561-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52945]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532267; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[104]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 19
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Z-2562-2026
Recall number Z-2562-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity 0
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2562-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5923]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532083; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[98]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 19
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Z-2563-2026
Recall number Z-2563-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity 0
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2563-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52943]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532274; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[132]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2564-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity 53 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2564-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17112]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429830116998 ; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[122]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2565-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity 8 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2565-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5309]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532311 ; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[99]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2566-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2566-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40173]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532090 ; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[114]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2567-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2567-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50174]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532298 ; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[159]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2568-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2568-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29447]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532120 ; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[93]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2569-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2569-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21586]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532328 ; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[143]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2570-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2570-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29450]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532106 ; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[126]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2571-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2571-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46807]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532304 ; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[150]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2572-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2572-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5926]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532137 ; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[39503]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2573-2026
Initiated April 30, 2026
Classification Class II
Status Ongoing
Quantity N/A
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2573-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52941]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Code information UDI: 06429811532335 ; All lots until the IFU update has been implemented
Distribution pattern US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[151]
FDA event record
· Exact recall-number query on openFDA
