Device recall
Z-0143-2012: Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit…
FDA device recall · Class II · Bioplate Inc
Key facts
| Recall number (Z-number) | Z-0143-2012 |
|---|---|
| Recall event | 55537 |
| Product | Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive… |
| Product code | JEY |
| Recalling firm | Bioplate Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 4, 2012 |
| 510(k) numbers | K082757 |
| FEI number | 1000518793 |
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