Device product
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
Z-1464-2018
Product summary
- Event
- Event 79798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6
- Official record key
device-enforcement:Z-1464-2018
Official wording
Reason: The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
Code information: Lot # M050225
Distribution pattern: US Distribution to the states of : MI, CA, OK, and Internationally to China, Canada,
Derived failure modes
-
Unknown
The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.