Device recall
Z-1872-2008: Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113…
FDA device recall · Class II · Biomet Microfixation, Inc.
Key facts
| Recall number (Z-number) | Z-1872-2008 |
|---|---|
| Recall event | 48461 |
| Product | Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. The system is used in trauma and reconstructive surgical procedures in the mid face and craniofacial skeleton. Used to support non-load bearing tissues of cranial… |
| Product code | JEY |
| Recalling firm | Biomet Microfixation, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 11, 2009 |
| 510(k) numbers | K955729, K980927 |
| FEI number | 1032347 |
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