Flexible Grip which is part of the Synthes Universal Nail System — Class II medical device recall Z-1062-2013
Terminated recall by Synthes USA HQ, Inc., reported 2013-04-17, distributed nationwide. Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Univer
| Recall number | Z-1062-2013 |
|---|---|
| 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 | 2013-04-05 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2015-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 328 |
| Model numbers | 355.28 |
Product
Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
Reason for recall
Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.
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-1062-2013. 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.