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U.S. Department of Health and Human Services

Class 3 Device Recall ADVANCE (R) CANAL FILLING STEM EXTENSION (13mm)

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  Class 3 Device Recall ADVANCE (R) CANAL FILLING STEM EXTENSION (13mm) see related information
Date Initiated by Firm September 22, 2009
Date Posted December 08, 2009
Recall Status1 Terminated 3 on December 16, 2010
Recall Number Z-0493-2010
Recall Event ID 53538
510(K)Number K061223  
Product Classification Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis - Product Code MBH
Product ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-2140, DIAMETER 13mm, 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 number: 098705612
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
5677 Airline Rd
Arlington TN 38002
For Additional Information Contact Debby Daurer
901-867-4601
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.
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 25 units
Distribution Nationwide, Columbia, Brazil, Portugal, UK, Belgium, Austria, and Greece
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 = MBH and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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