Device recall
Z-0471-2013: OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-0471-2013 |
|---|---|
| Recall event | 63612 |
| Product | OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable. |
| Product code | HTO |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 29, 2013 |
| FEI number | 1825034 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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