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U.S. Department of Health and Human Services

Class 2 Device Recall OMNI

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 Class 2 Device Recall OMNIsee related information
Date Initiated by FirmJuly 23, 2019
Create DateSeptember 05, 2019
Recall Status1 Terminated 3 on April 24, 2020
Recall NumberZ-2479-2019
Recall Event ID 83528
510(K)NumberK111572 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
ProductOMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
Code Information LOT # 31706
Recalling Firm/
Manufacturer		 OMNIlife science Inc.
480 Paramount Dr
Raynham MA 02767-1085
For Additional Information ContactChristina Rovaldi
508-822-6030
Manufacturer Reason
for Recall		Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOMNIlife science, Inc. sent an Urgent Medical Device Recall letter, dated July 23rd, 2019. 1. Identify the affected product from inventory and hold (quarantine) the product. 2. Return product to Omni at 480 paramount drive, Raynham, MA 02767 3. Acknowledge this notice by retuning the acknowledgement and receipt form by fax to 508-819-3390 or email to Omni-cs@coringroup.com For further information contact Christina Rovaldi, Regulatory Affairs Manager at 774-226-1847 or 800-448-6664. Return the attached Acknowledgement form by FAX to 508-819-3390 or by email to Omnics@coringroup.com. Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
Quantity in Commerce14 units
DistributionUS nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LZO
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