OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
Reported: September 11, 2019 Initiated: July 23, 2019 #Z-2480-2019
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.
Details
- Recalling Firm
- OMNIlife science Inc.
- Units Affected
- 22 units
- Distribution
- US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
- Location
- Raynham, MA
Frequently Asked Questions
What product was recalled? ▼
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128. Recalled by OMNIlife science Inc.. Units affected: 22 units.
Why was this product recalled? ▼
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 11, 2019. Severity: Moderate. Recall number: Z-2480-2019.
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