Device recall
Z-2213-2008: OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-2213-2008 |
|---|---|
| Recall event | 45806 |
| Product | 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. |
| Product code | KRO |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 13, 2009 |
| 510(k) numbers | K052685 |
| FEI number | 1825034 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database