Synthes Implant Holder for Synfix — Class II medical device recall Z-0405-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-12-04, distributed nationwide. Complaints were received which described the SynFix LR implant holder breaking at the interface between the im
| Recall number | Z-0405-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2013-10-08 |
| Classified | 2013-11-26 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2016-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 548 |
| Model numbers | 03.802.039 |
Product
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery
Reason for recall
Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.
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-0405-2014. 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.