FDA recall Z-1494-2021

Coltene Whaledent Inc · Class II · device

Product

Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741

Reason for recall

The incorrect dental pins were packaged and subsequently distributed.

Distribution

Worldwide distribution - US Nationwide distribution in the states of NJ, IN, NC, IL. GA, CA, NY, PA and the countries of Canada, Venezuela.

Key facts

Status
Ongoing
Initiation date
2021-03-18
Report date
2021-05-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cuyahoga Falls, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1494-2021