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Open, Classified

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

FDA Recall Z-1494-2021 · Posted None

Recalling FirmColtene Whaledent Inc
Recall StatusOpen, Classified
Product CodeEBL
Date Initiated2021-03-18
Product Quantity65 packs of 20 pins

Reason for Recall

The incorrect dental pins were packaged and subsequently distributed.

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.

Root Cause

Under Investigation by firm

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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