Device recall
Z-0959-2013: Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture…
FDA device recall · Class II · Allen Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0959-2013 |
|---|---|
| Recall event | 64509 |
| Product | Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures. |
| Product code | HST |
| Recalling firm | Allen Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2013 |
| FEI number | 1221538 |
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