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U.S. Department of Health and Human Services

Class 2 Device Recall Endoform Dermal Template

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  Class 2 Device Recall Endoform Dermal Template see related information
Date Initiated by Firm November 27, 2018
Date Posted November 02, 2018
Recall Status1 Terminated 3 on April 09, 2019
Recall Number Z-0379-2019
Recall Event ID 81161
510(K)Number K092096  
Product Classification Dressing, wound, collagen - Product Code KGN
Product Endoform Dermal Template 4x5, SKU 529313

Product Usage:
Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
Code Information Lot numbers: EDT-7I02 EDT-7L02
Recalling Firm/
Manufacturer		 AROA BIOSURGERY
2 Kingsford Smith Place
Airport Oaks New Zealand
Manufacturer Reason
for Recall		 Potential for pouch seal failure
FDA Determined
Cause 2		 Employee error
Action The firm sent a Customer Notification letter dated November 27, 2018. The letter identified the affected product, problem and actions to be taken. Customers are encouraged to visually inspect the seals on devices from these lots prior to use with particlar care. Should you observe a comprimised seal, please discard the device and select a new, fully sealed device for use.
Quantity in Commerce 8,853 total boxes
Distribution US 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.
510(K) Database 510(K)s with Product Code = KGN and Original Applicant = MESYNTHES LTD
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