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U.S. Department of Health and Human Services

Class 2 Device Recall Apligraf

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  Class 2 Device Recall Apligraf see related information
Date Initiated by Firm December 26, 2007
Date Posted January 24, 2008
Recall Status1 Terminated 3 on May 15, 2015
Recall Number Z-0675-2008
Recall Event ID 46250
PMA Number P950032 
Product Classification Wound Dressing - Product Code MGR
Product Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021
Code Information Lot Numbers: GS0711.20.01.2A and GS0711.22.01.2A
Recalling Firm/
Manufacturer		 Organogenesis, Inc.
150 Dan Road
Canton MA 02021-2820
For Additional Information Contact Patrick Bilbo
781-575-0775
Manufacturer Reason
for Recall		 Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative rod (bacillus) organism.
FDA Determined
Cause 2		 Material/Component Contamination
Action On 12/26/07, Organogenesis began to telephone the consignees to inform them of the recall. The firm sent a follow-up fax on 12/31/07 to all treating physicians who applied the product requesting patient status information. The Dear Doctor letter, dated December 27, 2007, was titled, "Subject: Potential contaminated Apligraf Units manufactured by Organogenesis, Inc." Consignees were instructed to return unused product, and monitor patients who received the Apligraf for adverse events.
Quantity in Commerce 177 units
Distribution Nationwide Distribution.
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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