Device recall
Z-0237-2022: OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is…
FDA device recall · Class II · OmniLife Science
Key facts
| Recall number (Z-number) | Z-0237-2022 |
|---|---|
| Recall event | 88890 |
| Product | OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. |
| Product code | LPH |
| Recalling firm | OmniLife Science |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 20, 2022 |
| 510(k) numbers | K041950 |
| FEI number | 3008342029 |
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