FDA · Medical device recall

SINGLES Carbide US-No…

Sept. 16, 2020 Class II

Date: Sept. 16, 2020
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: Hager & Meisinger Gmbh
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: US-dates between the product package label and the bar code display.
Distribution pattern: US Nationwide distribution including in the states of AZ, CA, FL, IN, NY, PA and TX.
Quantity: 144 units
Codes and lots: LOT R50753
Recall started: July 15, 2020
Device type: Bur, Dental
Root cause (FDA): Process control
What the company told customers: 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.
Recall number: Z-2937-2020

Source: FDA · Medical device enforcement report, recall number Z-2937-2020. The agency record governs; check it and the company before acting.

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