SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
Reported: February 3, 2021 Initiated: December 21, 2020 #Z-0922-2021
Product Description
SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
Reason for Recall
Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
Details
- Recalling Firm
- OMNIlife science Inc.
- Units Affected
- 2 units
- Distribution
- AL, ID, MD, NY, OK
- Location
- Raynham, MA
Frequently Asked Questions
What product was recalled? ▼
SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928. Recalled by OMNIlife science Inc.. Units affected: 2 units.
Why was this product recalled? ▼
Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 3, 2021. Severity: Moderate. Recall number: Z-0922-2021.
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