Device recall
Z-1249-2009: Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used…
FDA device recall · Class II · Synthes Spine
Key facts
| Recall number (Z-number) | Z-1249-2009 |
|---|---|
| Recall event | 51422 |
| Product | Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures. |
| Product code | HRS |
| Recalling firm | Synthes Spine |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2009 |
| 510(k) numbers | K021458 |
| FEI number | 3005180112 |
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