OMNIlife science Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
OMNIlife science Inc.
Lot Codes / Batch Numbers
Lot # 33035
Products Sold
Lot # 33035
OMNIlife science Inc. is recalling OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral c due to Stems missing porous coating on the device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Stems missing porous coating on the device.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, OK
Page updated: Jan 10, 2026