FDA recall Z-0465-2021

Coltene Whaledent Inc · Class II · device

Product

FG 57 100057X (100057X)

Reason for recall

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

Distribution

Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.

Key facts

Status
Ongoing
Initiation date
2020-10-20
Report date
2020-11-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cuyahoga Falls, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0465-2021