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U.S. Department of Health and Human Services

Class 2 Device Recall Transcend Hip System

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  Class 2 Device Recall Transcend Hip System see related information
Date Initiated by Firm August 18, 2003
Date Posted August 28, 2003
Recall Status1 Terminated 3 on January 29, 2004
Recall Number Z-1186-03
Recall Event ID 26948
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented - Product Code MRA
Product Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system.
Code Information Part No. Lot Serial No. 73003258 070A122950 71002846 101A147607 72003252 101A147579 71002846 01214750 73003258 020A116075 73003258 101A147616 71002846 101A147609 71002846 01214749 72003252 01214581 72003252 01215268 73003258 101A147617 73003258 01214576 74003664 101A147618 72003252 101A147580 71002846 048A080430 72003252 0124580 71002846 01214751 74003664 061A136523 72003252 119A112057 73003258 01214575 71002846 031A139399 72003252 101A147577 72003252 01214582 72003252 101A147578 71002846 039A100609 72003252 081A145884 
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
5677 Airline Rd
P.O. Box 100
Arlington TN 38002
For Additional Information Contact Robert Churinetz
901-867-4704
Manufacturer Reason
for Recall		 Wright Medical commercially distributed Transcend alumina acetabular shell liners lacking the required process validation.
FDA Determined
Cause 2		 Other
Action Distributors returned thier stock after May 8, 2003
Quantity in Commerce 133 units
Distribution nationwide
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.
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