Z-1494-2021Class II

Dental pins - TMS LINK PLUS Self-Threading Pins -

Name: Z-1494-2021 Dental pins - TMS LINK PLUS Self-Threading Pins -
Creator: Coltene Whaledent Inc
Published: 2021-03-18
License: https://open.fda.gov/license/

Coltene /Whaledent AG / initiated 2021-03-18 / Open, Classified / root cause: packaging

FDA source

Coltene Whaledent Inc began a recall of 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... on 2021-03-18. FDA classified it as Class II and gives the reason as "The incorrect dental pins were packaged and subsequently distributed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1494-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-18
Posted: 2021-04-26
Recalling firm: Coltene /Whaledent AG
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/Catalog number: L741
Product code: EBL Pin, Retentive And Splinting, And Accessory Instruments
Reason for recall: The incorrect dental pins were packaged and subsequently distributed.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On 3/18/2021, Coltene issued an Urgent Medical Device Recall notice via letter to customers notifying them the incorrect dental pins were packaged and subsequently distributed. The TMS LINK PLUS Self-Threading L741 Pins should be stainless steel, single sheer link pins that are gold-plated. The pins that were packed and distributed are titanium, double sheer, and not gold plated. The incorrectly packaged pin is too small for the drill, resulting in a hole that may be drilled too large for the pins. The pins may not engage the hole to effectively sheer.
Quantity in commerce: 65 packs of 20 pins
Distribution: Worldwide distribution - US Nationwide distribution in the states of NJ, IN, NC, IL. GA, CA, NY, PA and the countries of Canada, Venezuela.
Product codes and lots: Lot/Batch number: K39841

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1494-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1494-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-05	2021-04-26

Product code EBL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)