OMNIlife recalls SERF Novae Dual Mobility Cup Insert 49/28-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 specific hip replacement cup insert because it has higher than acceptable oxidation limits, which could lead to faster wear and the need for revision surgery.
The hip cup insert has higher than acceptable oxidation limits, which can cause the material to wear faster than expected. This increased wear rate may require revision surgery to replace the hip joint.
Patients who received the SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner for hip replacement surgery are affected. Those with the specific product code H6-24928 and lot number 28572 are most at risk.
Check for the product code H6-24928 and lot number 28572 on the hip cup insert. This product was intended for use with the Apex Modular Acetabular Cup in total hip replacement procedures.
Look for product code H6-24928 and lot number 28572 on the hip cup insert.
The cup insert has higher than acceptable oxidation limits, which could lead to faster wear and the need for revision hip surgery.
Check the product code and lot number on the insert. If it matches H6-24928 and 28572, contact OMNIlife for further instructions.
This recall is for potential increased wear rate leading to revision surgery, but the hazard is not immediate or life-threatening.
We’ve drafted a message you can send OMNIlife to request your refund or repair — edit it as you like.
Subject: Recall Z-0922-2021 — OMNIlife OMNIlife Hello, I own a OMNIlife that is covered by recall Z-0922-2021 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.
