Synthes Spiked Washers 13 — Class II medical device recall Z-0394-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-12-04, distributed nationwide. During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers
| Recall number | Z-0394-2014 |
|---|---|
| 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 | 2013-10-03 |
| Classified | 2013-11-26 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2015-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 3,087 |
| Reason classes | labeling |
| Lot numbers | 2335941, 2339634, 2397429, 2405812, 2440475, 2442736, 2496414, 5661855, 5663841 |
| Model numbers | 219.951 |
Product
Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
Reason for recall
During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.
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-0394-2014. 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.