Device recall
Z-2385-2012: Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under…
FDA device recall · Class II · Tedan Surgical Innovations Llc
Key facts
| Recall number (Z-number) | Z-2385-2012 |
|---|---|
| Recall event | 62899 |
| Product | Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for… |
| Product code | LXH |
| Recalling firm | Tedan Surgical Innovations Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 31, 2013 |
| FEI number | 3005726885 |
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