Device recall
Z-0649-2012: MANI Needle and Suture Pack, 8-0 PGA Absorbable, Model 2090, 30 cm suture and…
FDA device recall · Class II · Mani, Inc. - Kiyohara Facility
Key facts
| Recall number (Z-number) | Z-0649-2012 |
|---|---|
| Recall event | 60225 |
| Product | MANI Needle and Suture Pack, 8-0 PGA Absorbable, Model 2090, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue… |
| Product code | GAM |
| Recalling firm | Mani, Inc. - Kiyohara Facility |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 2013 |
| 510(k) numbers | K053636 |
| FEI number | 3002692886 |
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