Product Wiki · Recalls · U.S. FDA — Device Enforcement

HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam. — recall Z-2421-2020

U.S. FDA — Device Enforcement · United States · 2020-06-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2421-2020
Date of alert
2020-06-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Coltene Whaledent Inc
Product category
device
Product type
Devices
Reported risk: Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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