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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 Apligrafsee related information
Date Initiated by FirmJanuary 30, 2011
Date PostedMarch 23, 2011
Recall Status1 Terminated 3 on July 28, 2011
Recall NumberZ-1746-2011
Recall Event ID 57824
PMA NumberP950032 
Product Classification burn and wound dressing - Product Code MGR
ProductOrganogenesis 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  
FEI Number 1000148471
Recalling Firm/
Manufacturer		 Organogenesis, Inc.
150 Dan Road
Canton MA 02021-2820
For Additional Information ContactPatrick Bilbo
781-401-1155
Manufacturer Reason
for Recall		Product sterility compromised
FDA Determined
Cause 2		Material/Component Contamination
ActionOrganogenesis 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 Commerce50 units
Distributionnationwide.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = MGR
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