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Class 2 Device Recall ADVANCE DURAMER TIBIAL INSERT |
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Date Initiated by Firm |
November 24, 2009 |
Date Posted |
May 21, 2010 |
Recall Status1 |
Terminated 3 on October 21, 2010 |
Recall Number |
Z-1636-2010 |
Recall Event ID |
55436 |
510(K)Number |
K972770
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Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product |
ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312L, SIZE 3 LEFT 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: 679391 |
Recalling Firm/ Manufacturer |
Wright Medical Technology Inc 5677 Airline Rd Arlington TN 38002
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For Additional Information Contact |
Debbie Daurer 901-867-4601
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Manufacturer Reason for Recall |
The left medial pivot and right medial pivot inserts were co-mingled
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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 |
23 units |
Distribution |
Worldwide Distribution -- United States, The Netherlands, Italy, Republic of Korea and Japan. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = JWH and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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