OMNIlife recalls SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Lin: Higher oxidation limits may cause faster wear and revision surgery. Affected units sold with Apex Modular Acetabular Cup for hip replacements.
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 its acetabular liner has higher than acceptable oxidation levels, which could lead to faster wear and the need for revision surgery. This affects patients who have received the specific cup insert with the Apex Modular Acetabular Cup.
The acetabular liner has a higher oxidation limit than acceptable, which can cause the liner to wear down faster than expected. This increased wear rate may require revision surgery to replace the hip joint component.
Patients who received the SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner with the Apex Modular Acetabular Cup for hip replacements are most at risk. The recall applies to specific product codes and lot numbers.
Check if your hip replacement kit includes the product code H6-25128 with lot number 28413. The item is intended for use with the Apex Modular Acetabular Cup for total hip replacements.
Identify if your hip replacement kit includes the product code H6-25128 with lot number 28413.
The acetabular liner has a higher than acceptable oxidation limit, which may cause faster wear and require revision surgery.
No, the recall does not require stopping use; it is for patients who received the specific product code and lot number.
Check if your hip replacement kit includes product code H6-25128 with lot number 28413. If so, contact OMNIlife for further instructions.
We’ve drafted a message you can send OMNIlife to request your refund or repair — edit it as you like.
Subject: Recall Z-0920-2021 — OMNIlife OMNIlife Hello, I own a OMNIlife that is covered by recall Z-0920-2021 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.