Device recall
Z-0943-2013: INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX…
FDA device recall · Class II · Smith & Nephew Inc
Key facts
| Recall number (Z-number) | Z-0943-2013 |
|---|---|
| Recall event | 64342 |
| Product | INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation. |
| Product code | JDS |
| Recalling firm | Smith & Nephew Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 11, 2016 |
| 510(k) numbers | K981529 |
| FEI number | 1020279 |
At a glance
- 1–9 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