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.
FDA Recall Z-0169-2020 · Posted None
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Recalling FirmOMNIlife science Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2019-09-11
Date Terminated2020-04-27
Product Quantity3 units
Reason for Recall
Stems missing porous coating on the device.
Firm Action
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 [email protected]
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.
Root Cause
Under Investigation by firm
Distribution Pattern
OK, IL
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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