FDA Medical Device Recalls (openFDA)
Molnlycke Health Care, Inc: Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
- Recall number
- Z-2110-2017
- Recalling firm
- Molnlycke Health Care, Inc
- Product
- Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
- Status
- Open, Classified
- Initiated
- 2017-04-24
- Posted
- 2017-05-03
- Terminated
- not on file
- Reason
- Sterilization validation failure.
- Root cause
- Process design
- Action
- Consignees were notified by Urgent Safety Notice letter via certified mail on/about 4/24/2017.
- Quantity
- 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.
- Lot, serial or model codes
- Code: 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504 and 131506.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FZW
- Firm FEI
- 1629080
- Firm city
- Norcross
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28