Recall events
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Event 64195
Event summary
Timeline bucket January 11, 2013
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Synthes USA HQ, Inc.
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
3 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 3
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Z-0903-2013
Recall number Z-0903-2013
Initiated January 11, 2013
Classification Class II
Status Terminated
Quantity 2
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0903-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[6670]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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Inspect official wording and provenance
Reason for recall It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Code information Part number 487.831 - Lot numbers 7826459,7750064, 7667285, and 7806090.
Distribution pattern Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.
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[21201]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 3
Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
Z-0904-2013
Recall number Z-0904-2013
Initiated January 11, 2013
Classification Class II
Status Terminated
Quantity 24
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0904-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[53616]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Code information Part number 487.966 - Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336.
Distribution pattern Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.
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[21212]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 3
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
Z-0905-2013
Recall number Z-0905-2013
Initiated January 11, 2013
Classification Class II
Status Terminated
Quantity 18
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0905-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[53617]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Code information Part number 487.967 - Lot numbers 7883454, 3808876, 7824423, 3800758, 3817116, 3794466
Distribution pattern Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.
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[16264]
FDA event record
· Exact recall-number query on openFDA
