FDA Recall
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
·
Initiated July 15, 2020
Recall
- Recall Number
- Z-2937-2020
- Event Number
- 86147
- Firm
- Hager & Meisinger Gmbh Hansemannstr. 10 Neuss Germany
- FEI Number
- 3004169071
- Product Code
- EJL
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- July 15, 2020
- Terminated
- February 24, 2022
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.
Action
The US firm sent a recall letter to the affected consignees on 07/15/2020. On 07/23/2020 an UPDATED CUSTOMER NOTIFICATION - MEDICAL DEVICE RECALL letter with customer response form was sent to the consignees by US Mail.
Distribution
US Nationwide distribution including in the states of AZ, CA, FL, IN, NY, PA and TX.
Quantity
144 units