Recall Z-1241-2015 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Stryker Howmedica Osteonics Corp.
LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.
| Date | Mar 3, 2015 (initiated Feb 3, 2015) |
| Status | Terminated |
| Reason | Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem trunnion. |
| Root cause | Under Investigation by firm |
| Action | Branches/Agencies were notified of this action by e-mail on December 19, 2014 and were asked to quarantine affected devices. Notification Letters and Product Accountability Forms were sent to Hospital Risk Management and Chief of Orthopaedics via FedEx (with return receipt) by 2/3/2015. |
| Quantity | 9 units |
| Distribution | Distributed in the states of GA, MA, NC, NY & PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010757 | LFIT V40 FEMORAL HEAD COMPONENTS Howmedica Osteonics Corp., Apr 11, 2001 |