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U.S. Department of Health and Human Services

Class 2 Device Recall The Monoblock PressFit Hip Stem

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  Class 2 Device Recall The Monoblock PressFit Hip Stem see related information
Date Initiated by Firm September 11, 2019
Create Date October 21, 2019
Recall Status1 Terminated 3 on April 27, 2020
Recall Number Z-0169-2020
Recall Event ID 83844
510(K)Number K060072  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
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.
Code Information Lot # 33035
Recalling Firm/
Manufacturer		 OMNIlife science Inc.
480 Paramount Dr
Raynham MA 02767-1085
For Additional Information Contact Christina Rovaldi
508-822-6030
Manufacturer Reason
for Recall		 Stems missing porous coating on the device.
FDA Determined
Cause 2		 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 in Commerce 3 units
Distribution OK, IL
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = OMNI LIFE SCIENCE, INC.
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