OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
FDA Recall Z-2481-2019 · Posted None
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Recalling FirmOMNIlife science Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2019-07-23
Date Terminated2020-04-24
Product Quantity6
Reason for Recall
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Firm Action
OMNIlife science, Inc. sent an Urgent Medical Device Recall letter, dated July 23rd, 2019.
1. Identify the affected product from inventory and hold (quarantine) the product.
2. Return product to Omni at 480 paramount drive, Raynham, MA 02767
3. Acknowledge this notice by retuning the acknowledgement and receipt form by fax to 508-819-3390 or email to [email protected]
For further information contact Christina Rovaldi, Regulatory Affairs Manager at 774-226-1847 or 800-448-6664. Return the attached Acknowledgement form by FAX to 508-819-3390 or by email to [email protected].
Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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