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U.S. Department of Health and Human Services

Class 2 Device Recall OMNI K2 Hip Stem

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  Class 2 Device Recall OMNI K2 Hip Stem see related information
Date Initiated by Firm October 01, 2021
Create Date November 16, 2021
Recall Status1 Terminated 3 on July 20, 2022
Recall Number Z-0237-2022
Recall Event ID 88890
510(K)Number K041950  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.
Code Information UDI 00841690102496 Lot 38933
Recalling Firm/
Manufacturer		 OmniLife Science
480 Paramount Dr
Raynham MA 02767-1085
For Additional Information Contact Christina Rovaldi
508-822-6030
Manufacturer Reason
for Recall		 The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
FDA Determined
Cause 2		 Process control
Action Affected agents and representatives were notified by email, with initial communication sent via a quarantine form on 10/1/21. Additional notices titled "Urgent Medical Device Recall" were emailed out on October 15, 2021. Customers were instructed to immediately quarantine lot 38933 and return the product to OMNI. Customers were provided with a response form and asked to complete and return the form to the recalling company by FAX to 508-819-3390 or my email at christina.rovaldi@coringroup.com. For further information contact Christina Rovaldi, RA/QA 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 7
Distribution US Distribution to states of: Colorado and Virginia.
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 = APEX SURGICAL, LLC.
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