CLASS II ONGOING Device recall · Reported 5 May 2021 · FDA Enforcement Report

Dental pins - Tms Link Plus Self-Threading Pins recalled

Coltene Whaledent is recalling Dental pins - Tms Link Plus Self-Threading Pins, distributed nationwide in the US. The recall was initiated on 18 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot/Batch number: K39841

Quantity recalled65 packs of 20 pins

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1494-2021
FDA event ID: 87645
Recalling firm: Coltene Whaledent, Cuyahoga Falls, OH
Classification: Class II
Status: Ongoing
Recall initiated: 18 Mar 2021
FDA classified: 26 Apr 2021
Reported: 5 May 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Dental Devices

Timeline

18 Mar 2021	Recall initiated by company
26 Apr 2021	Classified by FDA	+39 days
5 May 2021	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The incorrect dental pins were packaged and subsequently distributed.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide California Georgia Illinois Indiana North Carolina New Jersey New York Pennsylvania

Questions about this recall

Why was it recalled?

The incorrect dental pins were packaged and subsequently distributed.

Which lots are affected?

Lot/Batch number: K39841

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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