FDA recall Z-2420-2020

Product

HYGENIC Simple Dam Kit, Model no. 60019066 - 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.

Reason for recall

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.

Distribution

Pending

Key facts

Status

Ongoing

Initiation date

2020-06-03

Report date

2020-07-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cuyahoga Falls, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2420-2020