Class 2 Device Recall Organogenesis Apligraf

• Date Initiated by Firm: February 21, 2011
• Date Posted: March 23, 2011
• Recall Status: Terminated 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: 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