Device recall
Z-1548-05: Product is an Orthopedic device contained in a Peel Foil Pouch. Product is…
FDA device recall · Class II · Linvatec Corp.
Key facts
| Recall number (Z-number) | Z-1548-05 |
|---|---|
| Recall event | 31392 |
| Product | Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121H QTY 1 3.5 x 10.5 mm Bio-Anchor with Disposable Driver, Preloaded with One #2 Herculine Suture***STERILE ***Linvatec A ConMed Company LINVATEC CORPORATION LARGO, FL 33773 USA***''. |
| Product code | JDI |
| Recalling firm | Linvatec Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 7, 2012 |
| 510(k) numbers | K042778 |
| FEI number | 1017294 |
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