Recall Z-1413-2017 ยท HWA Impactor
Encore Medical, Lp
RSP Impaction Fixture
| Date | Feb 9, 2017 |
| Status | Terminated |
| Reason | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. |
| Root cause | Device Design |
| Action | There are two field safety notices, one for Consignees who have surgeons that use the impaction fixtures (Verson 1) and one for Consignees who had previously indicated their surgeons do NOT use the impaction fixtures (Verson 2). The two recall notification letters were sent out on 2/9/17. |
| Quantity | 626 units |
| Distribution | US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.