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U.S. Department of Health and Human Services

Class 2 Device Recall Brennen Skin Graft Mesher

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  Class 2 Device Recall Brennen Skin Graft Mesher see related information
Date Initiated by Firm April 24, 2017
Date Posted May 03, 2017
Recall Status1 Open3, Classified
Recall Number Z-2110-2017
Recall Event ID 77121
Product Classification Expander, surgical, skin graft - Product Code FZW
Product Brennen Skin Graft Mesher.

Surgical instrument designed to expand skin grafts'
Code Information Code: 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504 and 131506.
Recalling Firm/
Manufacturer
Molnlycke Health Care, Inc
5550 Peachtree Pkwy Ste 500
Norcross GA 30092-2555
For Additional Information Contact Angela L. Bunn
470-375-0048
Manufacturer Reason
for Recall
Sterilization validation failure.
FDA Determined
Cause 2
Process design
Action Consignees were notified by Urgent Safety Notice letter via certified mail on/about 4/24/2017.
Quantity in Commerce 956 units
Distribution Domestic: U.S. Nationwide; Foreign: Austria, Australia, Bangladesh, Canada, Chile, Germany, Denmark, Finland, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Jordan, Korea, Kuwait, Malaysia, Norway, New Zealand, Peru, Saudi Arabia, Sweden Switzerland, Taiwan, Turkey, South Africa, United Arab Emirates.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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