FDAFDA · Food and drugs·Recall number Z-2480-2019
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
Published September 11, 2019 · Recall initiated: July 23, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- OMNIlife science Inc.
- Distributor
- US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
- Lot
- LOT # 31740
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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