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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.

FDA Recall Z-2937-2020 · Posted None

Recalling FirmHager & Meisinger Gmbh
Recall StatusTerminated
Product CodeEJL
Date Initiated2020-07-15
Date Terminated2022-02-24
Product Quantity144 units

Reason for Recall

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

Firm 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.

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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