OMNI K2 Hip recallZ-0237-2022 · OmniLife Science · initiated Oct 1, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from OmniLife Science or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
Affected agents and representatives were notified by email, with initial communication sent via a quarantine form on 10/1/21. Additional notices titled "Urgent Medical Device Recall" were emailed out on October 15, 2021. Customers were instructed to immediately quarantine lot 38933 and return the product to OMNI. Customers were provided with a response form and asked to complete and return the form to the recalling company by FAX to 508-819-3390 or my email at [email protected]. For further information contact Christina Rovaldi, RA/QA Manager at 774-226-1847 or 800-448-6664. Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
Recall details
- Recall number
- Z-0237-2022
- Status
- Terminated
- Initiated by the company
- Oct 1, 2021
- Recalling firm
- OmniLife Science
- Quantity
- 7
- Product code
- LPH
- FDA submissions
- K041950
- Distribution
- US Distribution to states of: Colorado and Virginia.
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.
Code information (models, lots, serial numbers)
UDI 00841690102496 Lot 38933
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OMNI K2 Hip 130006Omni Life Science, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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