FDA recall Z-2937-2020

Hager & Meisinger Gmbh · Class II · 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.

Reason for recall

US-dates between the product package label and the bar code display.

Distribution

US Nationwide distribution including in the states of AZ, CA, FL, IN, NY, PA and TX.

Key facts

Status
Terminated
Initiation date
2020-07-15
Report date
2020-09-16
Termination date
2022-02-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Neuss, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2937-2020