Device recall
Z-2583-2010: SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical…
FDA device recall · Class II · Synthes USA (HQ), Inc.
Key facts
| Recall number (Z-number) | Z-2583-2010 |
|---|---|
| Recall event | 56343 |
| Product | SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) The implant holder is used to place the implant into the vertebral disc space. |
| Product code | MQP |
| Recalling firm | Synthes USA (HQ), Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 18, 2014 |
| 510(k) numbers | K053508 |
| FEI number | 3005180112 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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