Class 3 Device Recall Organogenesis Apligraf

• Date Initiated by Firm: September 29, 2006
• Date Posted: October 24, 2006
• Recall Status: Terminated on March 12, 2007
• Recall Number: Z-0068-2007
• Recall Event ID: 36468
• PMA Number: P950032
• Product Classification: skin graft - Product Code MGR
• Product: Apligraf (Graftskin)
• Code Information: LOT: GS0609.05.01.2A Unit Numbers: 7, 8, 14, 15, 16, 18, 19, 25, 26, 29, 32, 34, 36, 40, 44, 46, 49, 52, 53, 54, 56, 58, 59, 60, 61, 63, 66, 68, 69, 70, 82 , 88, 91, 93, 94, 119, 120, 122, 126, 129, 130, 139, 142, 143, 144, 145 LOT:GS0609.05.02.1A Unit Numbers: 197, 198
• Recalling Firm/ Manufacturer: Organogenesis, Inc.; 150 Dan Road; Canton MA 02021-2820
• For Additional Information Contact: Patrick Bilbo; 782-401-1155 Ext. 1155
• Manufacturer Reason for Recall: Product pH out of specification
• FDA Determined Cause: Other
• Action: Organogenesis notified customers by fax on 9/29/06 through 10/2/06. Follow-Up telephone calls are being made. Users are requested to examine units for pH and return if product is out of spec., or verify unit was in spec for pH at time of use.
• Quantity in Commerce: 58
• 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