Device recall
Z-3198-2026: TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM…
FDA device recall · Class II · Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-3198-2026 |
|---|---|
| Recall event | 99558 |
| Product | TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene) |
| Product code | KRO |
| Recalling firm | Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K223528 |
| FEI number | 3003070421 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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