Recall Z-0417-2012 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Biomet, Inc.
OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications.
| Date | Jan 11, 2012 (initiated Nov 1, 2011) |
| Status | Terminated |
| Reason | Biomet has initiated this action following an investigation which identified that Part 150367, (OSS Cemented 1M Stem 13x150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem 14x150). |
| Root cause | Mixed-up of materials/components |
| Action | Biomet, Inc. sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 1, 2011 to the one distributor with the affected product. The letter described the product, problem, and actions to be taken by the customer. The letter instructs the customer to immediately locate and remove the affected product from inventory. Additionally, the customer was asked to complete and return a Response Form via fax to 574-372-1683. Call 574-372-3983 for questions related to this notice. |
| Quantity | 3 units & 1 pending release |
| Distribution | Distributed only in The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002757 | ONCOLOGY SALVAGE SYSTEM Biomet, Inc., Nov 24, 2000 |