Z-2937-2020Class II

SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 -

Name: Z-2937-2020 SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 -
Creator: Hager & Meisinger Gmbh
Published: 2020-07-15
License: https://open.fda.gov/license/

Hager & Meisinger GmbH / initiated 2020-07-15 / Terminated / root cause: manufacturing process

FDA source

Hager & Meisinger Gmbh began a recall of 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... on 2020-07-15. FDA classified it as Class II and gives the reason as "US-dates between the product package label and the bar code display". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2937-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-15
Posted: 2020-09-04
Terminated: 2022-02-24
Recalling firm: 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.
Product code: EJL Bur, Dental
Reason for recall: US-dates between the product package label and the bar code display.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 144 units
Distribution: US Nationwide distribution including in the states of AZ, CA, FL, IN, NY, PA and TX.
Product codes and lots: LOT R50753

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2937-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2937-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-16	2020-09-04

Product code EJL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)