Device recall
Z-2759-2019: TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal…
FDA device recall · Class II · Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-2759-2019 |
|---|---|
| Recall event | 83671 |
| Product | TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU… |
| Product code | MBH |
| Recalling firm | Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 6, 2020 |
| 510(k) numbers | K141056, K190991 |
| 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