Synthes Flexible Medullary Reamer — Class II medical device recall Z-1952-2013
Terminated recall by Synthes USA HQ, Inc., reported 2013-08-21, distributed nationwide. Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion o
| Recall number | Z-1952-2013 |
|---|---|
| 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 | 2013-06-11 |
| Classified | 2013-08-12 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2015-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 13,050 |
| Reason classes | foreign material |
| Model numbers | 359.106, 359.107, 359.108, 359.109, 359.110, 359.111, 359.112, 359.113, 359.114, 359.115 |
Product
Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
Reason for recall
Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.
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-1952-2013. 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.