Coltene Whaledent Inc: Medical Device Recall in 2021 - (Recall #: Z-1494-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 18, 2021

Date Posted: May 5, 2021

Recall Number: Z-1494-2021

Event ID: 87645

Reason for Recall:

The incorrect dental pins were packaged and subsequently distributed.

Status: Ongoing

Product Quantity: 65 packs of 20 pins

Code Information:

Lot/Batch number: K39841

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated