Recall Z-0656-2017 ยท HTO Reamer
Synthes (USA) Products LLC
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
| Date | Nov 23, 2016 (initiated Oct 31, 2016) |
| Status | Terminated |
| Reason | Non-conforming material used. |
| Root cause | Under Investigation by firm |
| Action | The firm, DePuy Synthes, mailed an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 11/2016 to customers who were affected by the recall. The letter described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory to identify and quarantine all affected products; if you have product to return call DePuy Synthes at 1-800-479-6329 to obtain an RA; complete and return the Verification Section with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132 within 30 business days; send a copy of the completed |
| Quantity | 198 units |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.