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U.S. Department of Health and Human Services

Class 2 Device Recall Organogenesis Apligraf

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  Class 2 Device Recall Organogenesis Apligraf see related information
Date Initiated by Firm February 21, 2011
Date Posted March 23, 2011
Recall Status1 Terminated 3 on July 28, 2011
Recall Number Z-1747-2011
Recall Event ID 58138
PMA Number P950032 
Product Classification burn and wound dressing - Product Code MGR
Product Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute
Code Information Packaging Lot:: GS1101-13-.02.2A Unit Numbers: 3, 13, 25, 28, 46, 76, 128 Exp. Date 23 Feb 2011
Recalling Firm/
Manufacturer		 Organogenesis, Inc.
150 Dan Road
Canton MA 02021-2820
For Additional Information Contact Patrick Bilbo
781-401-1155
Manufacturer Reason
for Recall		 Product sterility may be compromised
FDA Determined
Cause 2		 Packaging process control
Action Organogenesis contacted the accounts by telephone and fax on 2/24/11 to advise of the contamination and identification fo the organism for appropriate patient follow-up.
Quantity in Commerce 7 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.
PMA Database PMAs with Product Code = MGR and Original Applicant = ORGANOGENESIS, INC.
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