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U.S. Department of Health and Human Services

Class 2 Device Recall Organognesis Apligraf

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  Class 2 Device Recall Organognesis Apligraf see related information
Date Initiated by Firm September 27, 2009
Date Posted November 12, 2009
Recall Status1 Terminated 3 on March 31, 2010
Recall Number Z-0181-2010
Recall Event ID 53458
PMA Number P950032 
Product Classification Dressing, wound and burn, interactive - Product Code MGR
Product Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021.

Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers.
Code Information Lot: GS0909.01.01.1A, Expiration Date: October 8, 2009.  Unit Numbers: 7-12, 16-50, 52-59, 61-66 and 68-73.   
Recalling Firm/
Manufacturer		 Organogenesis, Inc.
150 Dan Road
Canton MA 02021-2820
For Additional Information Contact Kristine Burke
781-615-1818
Manufacturer Reason
for Recall		 Unit contaminated with Staphylococcus epidermidis
FDA Determined
Cause 2		 Packaging process control
Action Organogenesis, Inc. initiated a recall notification dated September 28, 2009 via fax to Physicians asking for return of unused affected product. If the unit was used, Physicians are advised to use standard wound care precautions to assure the safety of the patient. Users were asked to acknowledge receipt by completing and returning the notification to the firm. For further information, contact Organogenesis, Inc. at 1-888-432-5232.
Quantity in Commerce 60 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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