Device product
SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.
Z-2937-2020
Product summary
- Event
- Event 86147
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 units
- Official record key
device-enforcement:Z-2937-2020
Official wording
Reason: US-dates between the product package label and the bar code display.
Code information: LOT R50753
Distribution pattern: US Nationwide distribution including in the states of AZ, CA, FL, IN, NY, PA and TX.
Derived failure modes
-
Unknown
US-dates between the product package label and the bar code display.