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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 Apligrafsee related information
Date Initiated by FirmSeptember 27, 2009
Date PostedNovember 12, 2009
Recall Status1 Terminated 3 on March 31, 2010
Recall NumberZ-0181-2010
Recall Event ID 53458
PMA NumberP950032 
Product Classification Dressing, wound and burn, interactive - Product Code MGR
ProductOrganogenesis, 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.   
FEI Number 1000148471
Recalling Firm/
Manufacturer		 Organogenesis, Inc.
150 Dan Road
Canton MA 02021-2820
For Additional Information ContactKristine Burke
781-615-1818
Manufacturer Reason
for Recall		Unit contaminated with Staphylococcus epidermidis
FDA Determined
Cause 2		Packaging process control
ActionOrganogenesis, 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 Commerce60 units
DistributionNationwide Distribution
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = MGR
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