Device recall
Z-0809-2007: Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable…
FDA device recall · Class II · C P Medical
Key facts
| Recall number (Z-number) | Z-0809-2007 |
|---|---|
| Recall event | 37756 |
| Product | Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is sealed inside an inner foil pouch with an outside tyvek pouch. The outer tyvek pouch has the defective seal. No suture is exposed or… |
| Product code | GAM |
| Recalling firm | C P Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 1, 2008 |
| 510(k) numbers | K013274 |
| FEI number | 3002609049 |
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