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Open, Classified

Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'

FDA Recall Z-2110-2017 · Posted 2017-05-03

Recalling FirmMolnlycke Health Care, Inc
Recall StatusOpen, Classified
Product CodeFZW
Date Initiated2017-04-24
Product Quantity956 units

Reason for Recall

Sterilization validation failure.

Firm Action

Consignees were notified by Urgent Safety Notice letter via certified mail on/about 4/24/2017.

Root Cause

Process design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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