Drug recall
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral…
FDA recall event 88890 · Class II · OmniLife Science
Key facts
| Event ID | 88890 |
|---|---|
| Recall numbers | Z-0237-2022 |
| Recalling firm | OmniLife Science |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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. |
| Initiation date | Oct 1, 2021 |
| Report date | Nov 24, 2021 |
| Termination date | Jul 20, 2022 |
| City | Raynham |
| State | MA |
| Country | United States |
| FEI number | 3008342029 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: