Device recall
Z-0610-2009: Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate…
FDA device recall · Class II · Stryker Leibinger USA
Key facts
| Recall number (Z-number) | Z-0610-2009 |
|---|---|
| Recall event | 50180 |
| Product | Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Template, Stryker Leibinger GmbH & Co., Freiburg, Germany; REF # 55-28911. A mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and reconstruction. |
| Product code | JEY |
| Recalling firm | Stryker Leibinger USA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2009 |
| 510(k) numbers | K014263 |
| FEI number | 3005101424 |
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