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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 Device Recall ADVANCE TIBIAL WEDGE AUGMENT see related information
Date Initiated by Firm February 19, 2010
Date Posted March 31, 2010
Recall Status1 Terminated 3 on July 08, 2011
Recall Number Z-1215-2010
Recall Event ID 54677
510(K)Number K973524  
Product Classification Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. - 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 TN 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		 Employee error
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 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 = WRIGHT MEDICAL TECHNOLOGY, INC.
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