FDA-Device2019-11-27Class II

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:

Hager & Meisinger Gmbh
Hazard

Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade packaging.

Sold states
US: NV, PA, FL, SC, IA, NC-
Affected count
2500 burs
Manufactured in
Ronsdorferstrasse 22, N/A, Dusseldorf, N/A, Germany
Products
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:

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0493-2020

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