Coltene Whaledent Inc recalls Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental res…

Recall date

March 18, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1494-2021

FDA classification

Class II

Brand / firm

Coltene Whaledent Inc

Sold / distributed

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

Why it was recalled

The incorrect dental pins were packaged and subsequently distributed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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