Device recall
Z-1594-2011: ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1594-2011 |
|---|---|
| Recall event | 57915 |
| Product | ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850, Biomet Orthopedics Warsaw, IN. The torque limiting T-handle is used with attachments and hex drivers for preparation of the femur and for locking screw insertion at specified torque limit in Arcos hip procedures. |
| Product code | KWA |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 27, 2011 |
| FEI number | 1825034 |
At a glance
- None 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