The Recall Desk
ModerateFDA (Devices)·Z-1494-2021·Announced 2021-05-05

Coltene Whaledent Recalls TMS LINK PLUS Self-Threading Dental Pins

Coltene Whaledent Inc is recalling TMS LINK PLUS Self-Threading Dental Pins because incorrect pins were packaged and distributed. The recall affects 65 packs of 20 pins.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is limited to the distribution of incorrect product units rather than a high-risk pathogen or structural defect causing immediate harm.

Plain-English summary

Coltene Whaledent Inc is recalling TMS LINK PLUS Self-Threading Dental Pins, catalog number L741. The recall involves 65 packs of 20 pins, totaling 1,300 units. The specific lot number is K39841.

The recall was initiated because incorrect dental pins were packaged and subsequently distributed. These pins are intended to be implanted into teeth or used in laboratories for dental restoration purposes. The standard procedure for installation requires drilling a hole into the tooth tissue with an intraoral drill.

The affected products were distributed worldwide, including nationwide in the United States. Specific US states mentioned include New Jersey, Indiana, North Carolina, Illinois, Georgia, California, New York, and Pennsylvania. The products were also distributed in Canada and Venezuela. Consumers and dental professionals should stop using these pins and contact the manufacturer for instructions on return or replacement.

The recalled product

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/Cata

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot/Batch number: K39841

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically: