OMNIlife recalls SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner due to higher than acceptable oxidation limits, potentially requiring revision hip surgery.
Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
OMNIlife is recalling a hip replacement component because it has higher than acceptable oxidation limits, which could lead to faster wear and the need for revision surgery.
The acetabular liner has a higher oxidation limit than safe levels, which may cause it to wear faster than expected. This increased wear rate could lead to the need for revision surgery to replace the hip component.
Patients who received this hip replacement component during surgery are affected. Those with the specific product code H6-24728 and lot number 28624 are most at risk.
Check for product code H6-247:28 and lot number 28624 on the hip replacement component. This product was used with the Apex Modular Acetabular Cup for total hip replacements.
Reach out to OMNIlife science Inc. for guidance on the recall and next steps.
The product has a higher than acceptable oxidation limit, which may lead to faster wear and revision surgery. It is not safe for use as intended.
Contact OMNIlife science Inc. for guidance on the recall and next steps.
Look for product code H6-24728 and lot number 28624 on the hip replacement component.
We’ve drafted a message you can send OMNIlife to request your refund or repair — edit it as you like.
Subject: Recall Z-0921-2021 — OMNIlife OMNIlife Hello, I own a OMNIlife that is covered by recall Z-0921-2021 from OMNIlife. 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.
