PlainRecalls
FDA Devices Moderate 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.

Reported: September 16, 2020 Initiated: July 15, 2020 #Z-2937-2020

Product 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 for Recall

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

Details

Recalling Firm
Hager & Meisinger Gmbh
Units Affected
144 units
Distribution
US Nationwide distribution including in the states of AZ, CA, FL, IN, NY, PA and TX.
Location
Neuss

Frequently Asked Questions

What product was recalled?
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.. Recalled by Hager & Meisinger Gmbh. Units affected: 144 units.
Why was this product recalled?
US-dates between the product package label and the bar code display.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 16, 2020. Severity: Moderate. Recall number: Z-2937-2020.