Recall Z-1952-2013 ยท HTO Reamer
Synthes USA HQ, Inc.
Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
| Date | Aug 12, 2013 (initiated Jun 11, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Sythes notified direct accounts by letter on 6/11/13 and requested them to check their inventory and remove affected lots from stock. Synthes requested that affected lots be returned and to call Synthes at 1-800-479-6329 for a Return Authorization Number. Completion and return of the Verification section at the end of the letter was requested, including negative responses. |
| Quantity | 13,050 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.