Device recall
Z-3197-2026: ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518…
FDA device recall · Class II · Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-3197-2026 |
|---|---|
| Recall event | 99558 |
| Product | ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA 73-0110 73-0710 73-0910 SCORPIO RECESSED PATELLA 26MM 3044-0026 SCORPIO… |
| Product code | JWH |
| Recalling firm | Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K243817 |
| 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