OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
This recall has been terminated (originally issued September 11, 2019).
- Company
- Omnilife Science Inc.
- Recall Initiated
- September 11, 2019
- Terminated
- April 27, 2020
- Recall Number
- Z-0169-2020
- Quantity
- 3 units
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Stems missing porous coating on the device.
Distribution
OK, IL
Lot / Code Info
Lot # 33035
Root Cause
Under Investigation by firm
Action Taken
1. Identify the affected product in your inventory 2.Immediately hold or quarantine the Lot # 33035 3. Return Product to OMNI at 480 Paramount Drive, Raynham MA 02767 3. Fill out the acknowledgement form and return the Form by FAX to 508-819-3390 or my email to Omni-cs@coringroup.com For further information contact Christina Rovaldi, Regulatory Affairs Manager at 774- 226-1847 or 800-448-6664. Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
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