OMNIlife science Inc.: 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

Agency Publication Date: January 26, 2021

Affected Products

Product: 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

Lot Numbers:

Number

Product: 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

Lot Numbers:

Number

Product: 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

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87062

Status: Resolved

Manufacturer: OMNIlife science Inc.

Manufactured In: United States

Units Affected: 3 products (3 units; 3 units; 2 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: 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

Lot Numbers:

Number

Product: 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

Lot Numbers:

Number

Product: 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

Lot Numbers:

Number