FDA Device recall Z-0237-2022
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 h…
- FDA Device
- Class II
- terminated
- Published 2021-11-24
On 2021-11-24 the FDA classified a Class II recall of 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 h… by Omnilife Science, citing the device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0237-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-01 |
| Published | 2021-11-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Omnilife Science |
| Distribution | CO, VA |
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.
Reason
The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
Identifiers
| code_info | UDI 00841690102496 Lot 38933 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0237-2022%22
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