2 — Class II medical device recall Z-1021-2015
Terminated recall by Synthes, Inc., reported 2015-02-04. Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and brea
| Recall number | Z-1021-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-12-15 |
| Classified | 2015-01-28 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2016-08-18 |
| Countries outside the US | CA |
| Quantity | 973 |
| Reason classes | device malfunction |
| Lot numbers | 4519339, 4520830, 4527509, 4527510, 4528112, 4528678, 4529517, 4532428, 4542201, 4547106, 4547107, 4548231, 4552202, 4552203, 4562899, 4566835, 4572774, 4572775, 4578754, 4581035, 4593516, 4738938, 4768238, 4805320, 4805321, 4805622, 4805623, 4814351, 4869678, 4871808, 4880493, 4880495, 4888588, 4915212, 4915213, 4935249, 4935250, 4964319, 4964324, 4973229 and 91 more |
| Model numbers | 329.143 |
Product
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
Reason for recall
Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1021-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.