Device recall
Z-0384-2013: "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC…
FDA device recall · Class II · Linvatec Corp. dba ConMed Linvatec
Key facts
| Recall number (Z-number) | Z-0384-2013 |
|---|---|
| Recall event | 63077 |
| Product | "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction. |
| Product code | HTW |
| Recalling firm | Linvatec Corp. dba ConMed Linvatec |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 21, 2013 |
| FEI number | 1017294 |
At a glance
- None 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