Recall Z-2095-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Medacta Usa Inc
Evolis-Femoral Sizer Posterior Reference The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The femoral sizer is an alternate instrument that can be used in addition to the standard MIS femoral sizer. The Femoral Sizer Posterior Reference intended to be placed on the distal femoral cut and deter
| Date | Sep 11, 2009 |
| Status | Terminated |
| Reason | Medacta USA Inc is initiating a recall on the Femoral Sizer, an orthopedic manual surgical instrument, because the "L" and "R" markings are mislabeled which would cause incorrect usage. |
| Root cause | Process design |
| Action | The firm, Medacta USA Inc, sent an "Urgent Safety Notification" letter dated August 5, 2009, to the customers. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to check their inventory for devices listed, if found, to immediately sequester them and DO NOT use them in surgery. The customers were ask to please pack the affected femoral sizer(s) posterior reference for shipment to Medacta USA. Medacta informed the customers that Medacta USA personnel will contact them by telephone to provide them with an RMA number and the rew |
| Quantity | 5 |
| Distribution | Worldwide distribution: USA including states of Texas and Idaho and country of France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081023 | EVOLIS TOTAL KNEE SYSTEM Medacta International S.A., Oct 22, 2008 |