Device recall
Z-0014-2011: Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No…
FDA device recall · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-0014-2011 |
|---|---|
| Recall event | 50100 |
| Product | Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600. Made in Ireland; Howmedica Osteonics; 325 Corporate Drive, Mahwah, NJ 07430 Intended for primary or secondary reconstruction of the distal femur. |
| Product code | JWH |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 7, 2010 |
| 510(k) numbers | K920034 |
| FEI number | 3003070421 |
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