OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
This recall has been terminated (originally issued July 23, 2019).
- Company
- Omnilife Science Inc.
- Recall Initiated
- July 23, 2019
- Terminated
- April 24, 2020
- Recall Number
- Z-2480-2019
- Quantity
- 22 units
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Distribution
US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
Lot / Code Info
LOT # 31740
Root Cause
Nonconforming Material/Component
Action Taken
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 Omni-cs@coringroup.com 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 Omnics@coringroup.com. Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.