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Class 3 Device Recall ADVANCE (R) CANAL FILLING STEM EXTENSION (11mm) |
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Date Initiated by Firm |
September 22, 2009 |
Date Posted |
December 08, 2009 |
Recall Status1 |
Terminated 3 on December 16, 2010 |
Recall Number |
Z-0492-2010 |
Recall Event ID |
53538 |
510(K)Number |
K061223
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Product Classification |
Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis - Product Code MBH
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Product |
ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-0140, DIAMETER 11mm, LENGTH 140mm, 1 EACH, STERILE R, (FOR USE WITH CEMENT ONLY), SINGLE USE ONLY, (Ti6A14V), Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002 |
Code Information |
Lot numbers: 098705608 and 098705609 |
Recalling Firm/ Manufacturer |
Wright Medical Technology Inc 5677 Airline Rd Arlington TN 38002
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For Additional Information Contact |
Debby Daurer 901-867-4601
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Manufacturer Reason for Recall |
Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. The absence of alloying elements results in an area with less strength. For those instances where the product has been implanted, there is the potential increased risk of failure for these patients.
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FDA Determined Cause 2 |
Process control |
Action |
Wright Medical initiated the recall of the product on September 22, 2009 by contacting the distributors by telephone followed with letters addressed to the hospitals and surgeons dated October 9, 2009. At the firm, Customer Service is the contact for return instructions and replacement inventory. This phone number is 800-238-7117. Other questions regarding this matter are directed to 800-874-5630. |
Quantity in Commerce |
37 units |
Distribution |
Nationwide, Columbia, Brazil, Portugal, UK, Belgium, Austria, and Greece |
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 = MBH and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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