Device recall
Z-2116-2009: Uniflex Ti Buttress Thread Screw; TI Screw Buttress Thread Trauma Fixation…
FDA device recall · Class III · EBI, L.P.
Key facts
| Recall number (Z-number) | Z-2116-2009 |
|---|---|
| Recall event | 51725 |
| Product | Uniflex Ti Buttress Thread Screw; TI Screw Buttress Thread Trauma Fixation Systems, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 Intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. |
| Product code | HSB |
| Recalling firm | EBI, L.P. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 23, 2009 |
| 510(k) numbers | K982953 |
| FEI number | 2242816 |
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