Reported May 5, 2021 · Ongoing

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

Coltene Whaledent Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Coltene Whaledent Inc · 235 Ascot Pkwy · Cuyahoga Falls, OH · 44223-3701

Is this the product you have?

  • Dental pins - TMS LINK PLUS
  • Self-Threading Pins - Product Usageimplanted 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 numberL741
Lot codes and dates
  • Lot/Batch numberK39841
Amount recalled
65 packs of 20 pins

Where it was sold

Why it was recalled

The incorrect dental pins were packaged and subsequently distributed.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:21 PM UTC

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