Device recall
Z-3162-2011: Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal…
FDA device recall · Class II · Orthofix, Inc.
Key facts
| Recall number (Z-number) | Z-3162-2011 |
|---|---|
| Recall event | 58473 |
| Product | Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation System, Firebird Spinal Fixation System DDD Instrument Case. Product is intended for use with the Set Screw Driver (52-1061) and Adjustable Counter Torque Wrench (52-1265) to perform the… |
| Product code | NKB |
| Recalling firm | Orthofix, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2012 |
| 510(k) numbers | K092624 |
| FEI number | 2183449 |
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