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U.S. Department of Health and Human Services

Class 2 Device Recall ADVANCE DURAMER TIBIAL INSERT

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  Class 2 Device Recall ADVANCE DURAMER TIBIAL INSERT see related information
Date Initiated by Firm November 24, 2009
Date Posted May 21, 2010
Recall Status1 Terminated 3 on October 21, 2010
Recall Number Z-1637-2010
Recall Event ID 55436
510(K)Number K972770  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002.

Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients.
Code Information Lot Number: 681644
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 left medial pivot and right medial pivot inserts were co-mingled
FDA Determined
Cause 2		 Packaging process control
Action Wright Medical Technology, Inc. issued an "Urgent: Medical Device Voluntary Recall" notification dated November 24, 2009. The letters were addressed to distributors, hospital administrators, and surgeons. Consignees were asked to return all affected product in addition to a completed Response Form to the firm. For further information, contact Wright Medical Technology, Inc. at 1-800-874-5630.
Quantity in Commerce 47 units
Distribution Worldwide Distribution -- United States, The Netherlands, Italy, Republic of Korea and Japan.
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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