Synthes 3 — Class II medical device recall Z-2278-2013
Terminated recall by Synthes USA HQ, Inc., reported 2013-10-02, distributed nationwide. Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Numbe
| Recall number | Z-2278-2013 |
|---|---|
| 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 | 2013-03-08 |
| Classified | 2013-09-25 |
| Reported by FDA | 2013-10-02 |
| Terminated | 2015-05-21 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
| Reason classes | labeling |
| Lot numbers | 8037923 |
| Model numbers | 241.267 |
Product
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
Reason for recall
Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).
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-2278-2013. 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.