Recall Z-2213-2008 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Biomet, Inc.
OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043. Implant is part of a system used to replace the tibial portion of the knee joint.
| Date | Sep 17, 2008 (initiated Nov 7, 2007) |
| Status | Terminated |
| Reason | Mislabeled as to size: Product is labeled as reduced size, but is actually standard size. |
| Root cause | Labeling mix-ups |
| Action | Consignees were notified by an Urgent Medical Device Recall Notice letter dated 11/7/07. The letter required that use of the product be immediately discontinued and that components be returned to Biomet. Letters to hospital administrators and the five implanting surgeons were issued on/or about 5/6/08 advising them of the problem and to perform patient evaluations. |
| Quantity | 22 |
| Distribution | Nationwide Distribution --- including states of California, Florida, Illinois, Indiana, Massachusetts, Missouri, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia and Washington. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052685 | ORTHOPEDIC SALVAGE SYSTEM- OSS Biomet, Inc., Oct 27, 2005 |