Z-2480-2019 Class II Terminated
FDA device recall Z-2480-2019 was initiated by OMNIlife science Inc. on July 23, 2019 and is designated Class II. Reason for recall: Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery. The recall status is terminated (terminated April 24, 2020). Affected quantity: 22 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2019
- Initiation Date
- July 23, 2019
- Termination Date
- April 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 units
Product Description
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
Reason for Recall
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Distribution Pattern
US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
Code Information
LOT # 31740