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
Product summary
- 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
Incorrect packaging