Recall Z-0237-2022— OmniLife Science
Class II · Terminated
Class II FDA medical device recall by OmniLife Science, initiated 2021-10-01, terminated 2022-07-20. It names one FDA 510(k) clearance: K041950. 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..
- Recalling firm
- OmniLife Science
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-10-01
- Terminated
- 2022-07-20
- Firm location
- Raynham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.