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Recall Observatory FDA recall evidence

Device 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:

Z-0493-2020

November 07, 2018

Class II

Product summary

Firm
Hager & Meisinger Gmbh
Event
Event 83776
Status
Ongoing
Classification
Class II
Quantity
2500 burs
Official record key
device-enforcement:Z-0493-2020

Official wording

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

Code information: Lot #R23891 UDI: +E0HM26UN2453140099/$$8250523R23891+

Distribution pattern: US: NV, PA, FL, SC, IA, NC-

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Incorrect packaging