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 Class 2 Recall
see related information
Date Posted May 21, 2010
Recall Status1 Terminated on October 21, 2010
Recall Number Z-1637-2010
Recall Event ID 55436
Premarket Notification
510(K) Number
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/
Wright Medical Technology Inc
5677 Airline Rd
Arlington, Tennessee 38002
For Additional Information Contact Debbie Daurer
Manufacturer Reason
for Recall
The left medial pivot and right medial pivot inserts were co-mingled
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 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.