Z-0493-2020Class II

Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009...

Name: Z-0493-2020 Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009...
Creator: Hager & Meisinger Gmbh
Published: 2018-11-07
License: https://open.fda.gov/license/

Hager & Meisinger GmbH / initiated 2018-11-07 / Open, Classified / root cause: manufacturing process

FDA source

Hager & Meisinger Gmbh began a recall of Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm on 2018-11-07. FDA classified it as Class II and gives the reason as "Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0493-2020
Classification: Class II
Status: Open, Classified
Initiated: 2018-11-07
Posted: 2019-11-19
Recalling firm: Hager & Meisinger GmbH
Product: Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:
Product code: EJL Bur, Dental
Reason for recall: Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade packaging.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 10/29/2018, a medical device removal notice was mailed to the customers instructing them to do the following: 1. check your inventory for burs from the affected batch . Please return any affected instruments. You will receive a swift replacement. 2. If you have further distributed this product, please identify your customers in the response form attached . 3. Please complete the reposne orm and sent it bat to the firm at +1 (303268-5407 or by e-mail at [email protected] 4. For further questions, our customer service is available at +1 (303)268-5407
Quantity in commerce: 2500 burs
Distribution: US: NV, PA, FL, SC, IA, NC-
Product codes and lots: Lot #R23891 UDI: +E0HM26UN2453140099/$$8250523R23891+

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0493-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0493-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-27	2019-11-19

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)