Recall events
/
Event 73156
Event summary
Timeline bucket January 21, 2016
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Stryker Howmedica Osteonics Corp.
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
18 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 18
Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Z-0867-2016
Recall number Z-0867-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0867-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44136]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 0152-0218S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[17817]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 18
Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Z-0868-2016
Recall number Z-0868-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0868-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44150]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 0190-2000S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[22541]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 18
Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Z-0869-2016
Recall number Z-0869-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0869-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20839]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 12106450S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[17821]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 18
Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Z-0870-2016
Recall number Z-0870-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0870-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[2944]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1210-6451S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[18709]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 18
Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Z-0871-2016
Recall number Z-0871-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0871-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55634]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1213-9091S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[22370]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 18
Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Z-0872-2016
Recall number Z-0872-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0872-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24641]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1320-0016S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[17779]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 18
Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Z-0873-2016
Recall number Z-0873-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0873-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55651]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1806-0050S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[19626]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 18
Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Z-0874-2016
Recall number Z-0874-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0874-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14712]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1806-0051S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[19813]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 18
Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Z-0875-2016
Recall number Z-0875-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0875-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20846]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1806-0080S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[18673]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0876-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0876-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24638]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1806-0083S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[19649]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0877-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0877-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3073]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1806-0084S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[22509]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0878-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0878-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55643]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1806-0085S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[18497]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0879-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0879-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14672]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1806-0090S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[17710]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0880-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0880-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24630]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1806-0093S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[25657]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0881-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0881-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44142]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1806-1250S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[22336]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0882-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0882-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14715]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1806-1417S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[19610]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0883-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0883-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[49990]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1806-3030S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[22537]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0884-2016
Initiated January 21, 2016
Classification Class II
Status Terminated
Quantity 147,838 units in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
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-0884-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14713]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information Catalog number 1806-3031S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern US Nationwide Distribution
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[18678]
FDA event record
· Exact recall-number query on openFDA
