Recall Z-0169-2020 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
| Date | Sep 11, 2019 |
| Status | Terminated |
| Reason | Stems missing porous coating on the device. |
| Root cause | Under Investigation by 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 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. |
| Quantity | 3 units |
| Distribution | OK, IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060072 | MONOBLOCK PRESS-FIT HIP STEM Omni Life Science, Inc., Aug 24, 2006 |