OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
Reported: September 11, 2019 Initiated: July 23, 2019 #Z-2481-2019
Product Description
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
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
- 6
- 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 ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840. Recalled by OMNIlife science Inc.. Units affected: 6.
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-2481-2019.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11