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  Class 2 Device Recall ADVANCE DURAMER TIBIAL INSERT see related information
Date Initiated by Firm November 24, 2009
Date Posting Updated 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/
Wright Medical Technology Inc
5677 Airline Rd
Arlington TN 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
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.