Recall Z-0378-2017 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Stryker Howmedica Osteonics Corp.
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
| Date | Aug 29, 2016 |
| Status | Terminated |
| Reason | Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads. |
| Root cause | Under Investigation by firm |
| Action | Stryker notified their Branches/Agencies of this recall by e-mail on August 29, 2016 and they were asked to quarantine the affected devices. A Recall Notification Letter and Product Accountability Form was also sent on August 29, 2016 via UPS (with return receipt) to their Branches/Agencies/Hospital Risk Management and Surgeons. On October 11, 2016, Stryker sent an updated recall notification via UPS with return receipt to their affected customers because additional customers and lot numbers were identified. |
| Quantity | 42,519 units (total Catalog numbers) |
| Distribution | US Nationwide and Internationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022077 | 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) Howmedica Osteonics Corp., Jul 25, 2002 |