| Class 2 Device Recall Omnilife Science Apex Knee System Modular Tibia Augment | |
Date Initiated by Firm | August 09, 2012 |
Date Posted | September 13, 2012 |
Recall Status1 |
Terminated 3 on January 10, 2013 |
Recall Number | Z-2373-2012 |
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 4 x 4mm
Ref: KC-54040.
The Apex Knee System is intended for use as a primary or revision total knee replacement. |
Code Information |
Lot Numbers: 8395,8823, 8929, 8969, 8984, 9166, 10319, 10740, 11703 |
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 | 270 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
|
|
|
|