Synthes Soft Tissue Retractor Small Extendible Offset blade… — Class II medical device recall Z-0341-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-11-27, distributed nationwide. The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.
| Recall number | Z-0341-2014 |
|---|---|
| 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 | 2013-09-24 |
| Classified | 2013-11-18 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2015-06-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 374 |
| Reason classes | device malfunction |
| Lot numbers | 1776332, 1834589, 1855361, 1893067, 1903596, 1952258, 1986932, 3067805, 3150691, 3179456, 3186865, 3220973, 3241083, 325.01, 3268079, 3360992, 3719234, 3818913, 4948929, 4994679, 4994680, 5031083, 5031085, 5391773, 5420979, 5420980, 5476369, 5476370, 5510070, 5544585, 5546329, 5563699, 5569041, 5624246, 5657366, 5677289, 5759764, 5759765, 5779363, 7698954 and 1 more |
| Model numbers | 1776332, 1834589, 1855361, 1893067, 1903596, 1952258, 1986932, 3067805, 3150691, 3179456, 3186865, 3220973, 3241083, 325.01, 3268079, 3360992, 3719234, 3818913, 4948929, 4994679, 4994680, 5031083, 5031085, 5391773, 5420979 and 16 more |
Product
Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Reason for recall
The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.
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-0341-2014. 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.