Device product

OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128

Z-2480-2019

July 23, 2019

Class II

Product summary

Firm: OMNIlife science Inc.
Event: Event 83528
Status: Terminated
Classification: Class II
Quantity: 22 units
Official record key: device-enforcement:Z-2480-2019

Official wording

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

Code information: LOT # 31740

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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