Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
FDA device recall Z-2110-2017 · posted 2017-05-03 · Open, Classified
Recall details
- Recalling firm
- Molnlycke Health Care, Inc
- Reason for recall
- Sterilization validation failure.
- Action taken
- Consignees were notified by Urgent Safety Notice letter via certified mail on/about 4/24/2017.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- FZW
- Quantity affected
- 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, M
- Date initiated
- 2017-04-24
- Date posted
- 2017-05-03
- Location
- Norcross, GA
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