Recall Z-0644-2017 ยท HTO Reamer
Synthes (USA) Products LLC
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
| Date | Nov 19, 2016 (initiated Oct 3, 2016) |
| Status | Terminated |
| Reason | The peel pouches for the affected reaming rods and extraction hooks are delaminating. |
| Root cause | Nonconforming Material/Component |
| Action | DePuy Synthes mailed a Customer Safety Advisory Notice on October 19, 2016 to affected customers advising them of the malfunction, potential risks and the actions needed to be taken to avoid injury, as they work on a solution to correct the problem. |
| Quantity | 2,157 units |
| Distribution | Distributed Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.