OmniLife Science Recall 88890
Description: 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.
OmniLife Science Recall 88890 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0237-2022 |
| Event ID | 88890 |
| Event Description | 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 Type | Devices |
| Distribution | US Distribution to states of: Colorado and Virginia. |
| Quantity | 7 |
| Recall 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. |
| Device Classification | 20211124 |
| Device Code Info | UDI 00841690102496 Lot 38933 |
| Center Classification Date | 20211116 |
| Recall Initiation Date | 20211001 |
| Recalling Firm | OmniLife Science |
| Initial Notification | |
| Similar To |