Synthes 4 — Class II medical device recall Z-0401-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-12-04, distributed in CO. A plate was inadvertently released to a sales consultant that was restricted for sale.
| Recall number | Z-0401-2014 |
|---|---|
| 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 | 2013-05-29 |
| Classified | 2013-11-26 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2015-05-21 |
| Distributed | CO |
| Quantity | 1 |
| Lot numbers | 3771678 |
| Model numbers | 04.124.406S |
Product
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
Reason for recall
A plate was inadvertently released to a sales consultant that was restricted for sale.
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-0401-2014. 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.