Z-0237-2022 Class II Terminated
FDA device recall Z-0237-2022 was initiated by OmniLife Science on October 1, 2021 and is designated Class II. 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. The recall status is terminated (terminated July 20, 2022). Affected quantity: 7.
Recall Details
- Product Type
- Devices
- Report Date
- November 24, 2021
- Initiation Date
- October 1, 2021
- Termination Date
- July 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
Product 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.
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.
Distribution Pattern
US Distribution to states of: Colorado and Virginia.
Code Information
UDI 00841690102496 Lot 38933