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U.S. Department of Health and Human Services

Class 2 Device Recall ADVANCE TIBIAL WEDGE AUGMENT

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 Class 2 Recall
ADVANCE TIBIAL WEDGE AUGMENT
see related information
Date Posted March 31, 2010
Recall Status1 Terminated on July 08, 2011
Recall Number Z-1215-2010
Recall Event ID 54677
Premarket Notification
510(K) Number
K973524 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product ADVANCE TIBIAL WEDGE AUGMENT, REF KTAG-W315, SIZE 3/2+, Thickness 15 DEG, SURFACE NON-POROUS, 1 EACH, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. The device is intended for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) Noninflammatory degenerative joint disease, 2)inflammatory joint disease, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed and 5) treatment of fractures that are unmanageable using other techniques. (For cement use only).
Code Information Lot numbers: 087441267 and 097441268.
Recalling Firm/
Manufacturer
Wright Medical Technology Inc
5677 Airline Rd
Arlington, Tennessee 38002
For Additional Information Contact Debbie Daurer
901-867-4601
Manufacturer Reason
for Recall
The product contained screws with the incorrect length (incorrectly contained 15 mm length screws instead of the correct 5 mm length screws).
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action The firm initiated their recall of the product by letter on February 19, 2010. The notification letters were addressed to distributors, hospital administrators, and surgeons with a fax back response form. The letter described the affected product and reason for the recall. Customers were instructed to examine their inventory and return the recalled product to Wright Medical Technology, Inc. Customers may contact Customer Service by calling 1-800-238-7117 for return instructions and replacement inventory. Direct questions regarding this matter to Wright Medical Technology, Inc. by calling 1-800-874-5630.
Quantity in Commerce 47 units
Distribution Worldwide Distribution -- United States, Canada, Netherlands, Germany, Japan, S. Korea, UK, Czech Republic, Turkey and Brazil.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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