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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 02, 2003
Date Posted June 04, 2003
Recall Status1 Terminated 3 on November 03, 2003
Recall Number Z-0904-03
Recall Event ID 26327
PMA Number P000036 
Product Classification Dressing, Wound And Burn, Interactive - Product Code MGR
Product Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in..
Code Information Lot 116098
Recalling Firm/
Manufacturer		 Smith and Nephew Wound Management (La Jolla)
10933 N Torrey Pines Road
Ste 200
San Diego CA 92037
For Additional Information Contact Dionicia B. Reblando
858-754-3700
Manufacturer Reason
for Recall		 Did not meet finished device specifications for the DNA criteria.
FDA Determined
Cause 2		 Other
Action Recall was by telephone on or about May 2, 2003 and by letter on May 7, 2003. Product is to be returned.
Quantity in Commerce 22
Distribution To hospitals 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.
PMA Database PMAs with Product Code = MGR and Original Applicant = SHIRE REGENERATIVE MEDICINE
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