Device recall
Z-0183-06: Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral…
FDA device recall · Class II · Theken Spine LLC
Key facts
| Recall number (Z-number) | Z-0183-06 |
|---|---|
| Recall event | 33713 |
| Product | Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System). |
| Product code | LXH |
| Recalling firm | Theken Spine LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 21, 2007 |
| 510(k) numbers | K041592 |
| FEI number | 3002498892 |
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