Device recall
Z-1677-2012: Restoration HA Reduced Neck 255 mm Long Stem Manufactured by Stryker Howmedica…
FDA device recall · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-1677-2012 |
|---|---|
| Recall event | 61338 |
| Product | Restoration HA Reduced Neck 255 mm Long Stem Manufactured by Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The Restoration HA cementless Hip System is designed to address the problems of revision surgery where extensive fixation both distally and proximally is required for… |
| Product code | MEH |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2013 |
| 510(k) numbers | K951671 |
| 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