Lower riskMedical device recall · FDA · Published December 21, 2020
OMNIlife SERF Novae Dual Mobility Cup Insert Recall: Higher Wear Risk
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
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Contact the company
📍Recalling firmOMNIlife science Inc.480 Paramount Dr · Raynham, MA 02767-1085
“OMNIlife SERF Novae Dual Mobility Cup Insert Recall: Higher Wear Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63630-omnilife-serf-novae-dual-mobility-cup-insert-recall-higher-wear. Based on FDA recall #Z-0922-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0922-2021%22&limit=1).
The FDA announced on 2020-12-21 that OMNIlife science Inc. is recalling SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liners due to a higher than acceptable oxidation limit. This defect may cause increased wear rates, potentially requiring patients to undergo revision surgery.
How to tell if you have it
Brand: OMNIlife
Product: SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner
Intended for use with the Apex Modular Acetabular Cup
Product Code: H6-24928
Lot Number: 28572
Quantity: 2 units
Sold in AL, ID, MD, NY, OK
The hazard
The acetabular liners have a higher than acceptable oxidation limit. According to the FDA, this may lead to a higher wear rate for the liners and require revision surgery.
Context
GovInfoNow's records show OMNIlife science Inc. has 6 other recalls on record since 2017-11-20. On 2019-09-11, the company recalled the OMNI Hip System Model HC-00070 due to missing porous coating hazards. Other recent recalls of similar products include Howmedica OMNIFIT Series I Acetabular Insert Recall (2026-07-30), Howmedica TRIATHLON Hinge Insert Recall (2026-07-30), and Howmedica Osteonics Recalls Hip Implant Components Due to Oxidation Risk (2026-07-30).
How to tell if you have this one
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.
Brand
OMNIlife
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
AL, ID, MD, NY, OK
Recall number
Product, codes & lots
Quantity
Z-0920-2021
SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128; Lot Number: 28413
3 units
Z-0921-2021
SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728; Lot Number: 28624
3 units
Z-0922-2021
SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928; Lot Number: 28572
2 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for product code H6-24928 and lot number 28572 on the hip cup insert.
Where it went and when
Where it was distributed
Distributed in 5 states.
Listed by the agency
Not listed
FDA distribution: “AL, ID, MD, NY, OK” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Idaho, Maryland, New York, Oklahoma.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0922-2021 (December 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0922-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.