Large Combination Clamp/Large External Fixation System — Class II medical device recall Z-0941-2013
Terminated recall by Synthes USA HQ, Inc., reported 2013-03-20, distributed nationwide. The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenche
| Recall number | Z-0941-2013 |
|---|---|
| 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 | 2013-01-11 |
| Classified | 2013-03-11 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2015-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 136 |
| Lot numbers | 6581191, 6581193, 6582333, 6602070 |
| Model numbers | 390.005 |
Product
Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Reason for recall
The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.
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-0941-2013. 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.