OmniLife Science recalls OMNI K2 Hip Stem (Product Code 130006) due to missing grit blasting on the proximal surface, which may cause undersizing during hip replacement surgery.
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.
OmniLife Science is recalling its OMNI K2 Hip Stem (Product Code 130006) because it lacks grit blasting on the proximal surface. This could lead to the hip stem being too small during surgery, requiring revision. Patients with this implant should contact the manufacturer for guidance.
The hip stem lacks grit blasting on the proximal surface, which is a process that ensures the correct size and fit during surgery. Without this, the implant might be undersized, requiring additional surgery to fix.
Patients who received the OMNI K2 Hip Stem (Product Code 130006) for hip replacement surgery are affected. Those with this specific implant model are most at risk.
Check for the product code 130006 on the hip stem. The recall applies to the OMNI K2 Hip Stem used in primary total hip replacements with UDI 00841690102496 and Lot 38933.
Reach out to OmniLife Science directly for guidance on next steps regarding your implant.
The recall indicates a potential risk of undersizing during surgery, but it does not describe a risk of serious injury or death in normal use.
Check for the product code 130006 on the hip stem, and look for UDI 00841690102496 and Lot 38933.
Contact OmniLife Science directly for guidance on next steps.
We’ve drafted a message you can send OmniLife Science to request your refund or repair — edit it as you like.
Subject: Recall Z-0237-2022 — OmniLife Science OmniLife Science Hello, I own a OmniLife Science that is covered by recall Z-0237-2022 from OmniLife Science. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
