Device recall
Z-2334-2010: Triathlon Total Knee System Primary Tibial Baseplate; Sterile, Made in Ireland…
FDA device recall · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-2334-2010 |
|---|---|
| Recall event | 53427 |
| Product | Triathlon Total Knee System Primary Tibial Baseplate; Sterile, Made in Ireland. Howmedica Osteonics 325 Corporate Drive Mahwah, NJ 07430 The Triathlon system is comprised of a femoral component, tibial tray, and tibial insert that are intended to be used in total knee arthroplasty (if replacement of… |
| Product code | JWH |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 27, 2012 |
| 510(k) numbers | K031729, K040267 |
| 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