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U.S. Department of Health and Human Services

Class 2 Device Recall Omnilife Science Apex Knee System Modular Tibia Augment

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  Class 2 Device Recall Omnilife Science Apex Knee System Modular Tibia Augment see related information
Date Initiated by Firm August 09, 2012
Date Posted September 13, 2012
Recall Status1 Terminated 3 on January 10, 2013
Recall Number Z-2371-2012
Recall Event ID 62912
510(K)Number K094017  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm
Ref: KC-54020.

The Apex Knee System is intended for use as a primary or revision total knee replacement.
Code Information Lot Numbers: 8362, 8524, 8853, 8988, 8992, 9021, 9040, 9152, 9883, 9885, 10221, 10318, 10726, 11478
Recalling Firm/
Manufacturer		 Omni Life Science
50 Oconnell Way
Unit 10
East Taunton MA 02718
Manufacturer Reason
for Recall		 The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
FDA Determined
Cause 2		 Packaging
Action Omnilife Science contacted affected customers by phone and sent an "URGENT MEDICAL DEVICE RECALL" e-mail on August 9, 2012. The e-mail identifies the product, problem, and actions to be taken by the customers. Customers with questions regarding product return should contact Customer Service at 800-448-6664. Customers with questions regarding the recall should contact the firm at 774-226-1845.
Quantity in Commerce 286 units
Distribution Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.
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 = JWH and Original Applicant = OMNI LIFE SCIENCE, INC.
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