Device recall
Z-0507-2010: OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol…
FDA device recall · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-0507-2010 |
|---|---|
| Recall event | 53386 |
| Product | OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325 Corporate Drive, Mahwah, NJ 07430. Surgical protocols instruct surgeons on proper surgical technique. |
| Product code | LZO |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 17, 2013 |
| 510(k) numbers | K022555 |
| 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