Device recall
Z-2308-2009: Fixed Closed Screw (Ti); 5.0MM (D) x 25MM (L); Made in USA, Biomet Spine…
FDA device recall · Class III · EBI, L.P.
Key facts
| Recall number (Z-number) | Z-2308-2009 |
|---|---|
| Recall event | 51730 |
| Product | Fixed Closed Screw (Ti); 5.0MM (D) x 25MM (L); Made in USA, Biomet Spine, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application… |
| Product code | MNH |
| Recalling firm | EBI, L.P. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 23, 2009 |
| 510(k) numbers | K993956 |
| FEI number | 2242816 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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