OMNIlife science Inc.: Medical Device Recall in 2019 - (Recall #: Z-2479-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328

Product Classification:

Class II

Date Initiated: July 23, 2019

Date Posted: September 11, 2019

Recall Number: Z-2479-2019

Event ID: 83528

Reason for Recall:

Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.

Status: Terminated

Product Quantity: 14 units

Code Information:

LOT # 31706

Distribution Pattern:

US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.

Voluntary or Mandated:

Voluntary: Firm initiated