Synthes 3 — Class II medical device recall Z-0986-2014
Terminated recall by Synthes, Inc., reported 2014-02-26, distributed nationwide. Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
| Recall number | Z-0986-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-01-27 |
| Classified | 2014-02-16 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2015-12-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH |
| Quantity | 1,132,096 |
| Reason classes | labeling |
| Lot numbers | 4440270 |
| Model numbers | 357.399 |
Product
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Reason for recall
Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
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-0986-2014. 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.