Device recall
Z-1684-2011: SCORPIO-FLEX CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics…
FDA device recall · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-1684-2011 |
|---|---|
| Recall event | 56332 |
| Product | SCORPIO-FLEX CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. The Tibial trial are utilized during surgery to assess the overall component fit, ligament stability, and joint range of motion prior to final implantation of the insert to… |
| Product code | LXH |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 29, 2017 |
| FEI number | 3003070421 |
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