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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 Apligraf see related information
Date Initiated by Firm August 02, 2010
Date Posted September 28, 2010
Recall Status1 Terminated 3 on March 10, 2011
Recall Number Z-2589-2010
Recall Event ID 56543
PMA Number P950032 
Product Classification Wound and Burn Interactive Dressing - Product Code MGR
Product Apligraf is supplied as a living, bi-layered skin substitute.
Article Number: GS100

Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy.
Code Information Lot # GS1007.06.03.1A Unit numbers: 146-, 148, 149, 150, 151, 152, 154, 155, 157, 158, 159, 160, 162, 163, 172, 173, 174, 175, 176, 177, 178, 180, 181, 182, 184, 185, 186, 187, 188, 189, and 190.
Recalling Firm/
Manufacturer		 Organogenesis, Inc.
150 Dan Road
Canton MA 02021-2820
For Additional Information Contact Same
781-401-1155
Manufacturer Reason
for Recall		 Product is contaminated with a yeast identified as Pseudozyma antarctica.
FDA Determined
Cause 2		 Process control
Action Organogenesis notified accounts by telephone, e-mail or fax on 8/2/010 to remove from use and return recalled units. If unit was applied to patient then monitor for adverse events. The Notification Letter dated August 6, 2010, described the issue and provided instructions for customers. Customers are to place the affected unit on hold for its return to the firm. The firm will contact customers to make arrangements for its return. Replacements have already been sent. If the affected unit has already been applied, the patients should be monitored closely for any potential adverse events. An Organogenesis Medical Affairs rep will be in contact regarding patient follow up. Customers are to complete the attached form and fax it back to the number provided. Questions should be directed to the Medical Information Center at 1-888-432-5232.
Quantity in Commerce 32 units
Distribution Nationwide Distribution -- AL, AZ, CA, CO, IL NC, PA, TN, and VA.
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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