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 | |
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