Device recall
Z-1640-2009: In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S Used with…
FDA device recall · Class II · Synthes Spine
Key facts
| Recall number (Z-number) | Z-1640-2009 |
|---|---|
| Recall event | 51702 |
| Product | In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in adults and children. |
| Product code | HRS |
| Recalling firm | Synthes Spine |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2010 |
| 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