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Class 2 Device Recall Organogenesis Apligraf |
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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
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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
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For Additional Information Contact |
Patrick Bilbo 781-401-1155
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Manufacturer Reason for Recall |
Product sterility compromised
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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
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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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PMA Database |
PMAs with Product Code = MGR and Original Applicant = ORGANOGENESIS, INC.
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