Device recall
Z-1379-2021: Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System…
FDA device recall · Class II · Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-1379-2021 |
|---|---|
| Recall event | 87517 |
| Product | Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set I-K3834CG1L Specialty Triathlon TS… |
| Product code | JWH |
| Recalling firm | Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2024 |
| 510(k) numbers | K132624, K172326 |
| 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