Device product
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Z-2110-2017
Product summary
- Event
- Event 77121
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 956 units
- Official record key
device-enforcement:Z-2110-2017
Official wording
Reason: Sterilization validation failure.
Code information: Code: 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504 and 131506.
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.
Derived failure modes
-
Unknown
Sterilization validation failure.