Device recall
Z-1216-2024: USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following…
FDA device recall · Class II · United Orthopedic Corporation
Key facts
| Recall number (Z-number) | Z-1216-2024 |
|---|---|
| Recall event | 93858 |
| Product | USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x150mm, PE25153117… |
| Product code | KRO |
| Recalling firm | United Orthopedic Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K190100 |
| FEI number | 1000395711 |
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