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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 January 30, 2011
Date Posted March 23, 2011
Recall Status1 Terminated 3 on July 28, 2011
Recall Number Z-1746-2011
Recall Event ID 57824
PMA Number P950032 
Product Classification burn and wound dressing - Product Code MGR
Product Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute
Code Information Lot Number GS1012.28.05.2A Unit Numbers: 2, 5, 6, 7,8, 9,10, 11, 12, 13, 14, 15,16, 17,18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 29, 31, 32, 34, 36, 37, 38, 39, 40, 41, 42,43, 44, 45,46, 50,51, 52, 53, 55, 56, 69 ,135, 200  
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 compromised
FDA Determined
Cause 2		 Material/Component Contamination
Action Organogenesis notified accounts on Sunday, January 30, 2011, via fax and phone. The Company will collect written confirmation from the affected customers that they have been notified of the recall. Sales representatives for the affected customers have been directed to visit the customers as soon as possible Monday morning to assist in the recall and prevent additional applications of the product. Apligraf Medical Affairs personnel will provide clinical support to treating physicians, and update them as new information on microbial contamination and antibiotic susceptibility becomes available. Units not applied have been requested to be returned to Organogenesis
Quantity in Commerce 50 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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