Class 2 Device Recall Brennen Skin Graft Mesher

• Date Initiated by Firm: April 24, 2017
• Date Posted: May 03, 2017
• Recall Status: Open, 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: 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.