FDA Enforcement
Class II
Terminated
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.
Recall: Z-2937-2020
·
Reported September 16, 2020
Enforcement
- Recall Number
- Z-2937-2020
- Event ID
- 86147
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Hager & Meisinger Gmbh
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 16, 2020
- Initiation Date
- July 15, 2020
- Classification Date
- September 4, 2020
- Termination Date
- February 24, 2022
- Address
- Hansemannstr. 10, Neuss, N/A, Germany
Description
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.
Reason
US-dates between the product package label and the bar code display.
Code Info
LOT R50753
Distribution
US Nationwide distribution including in the states of AZ, CA, FL, IN, NY, PA and TX.
Quantity
144 units