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Coltene Whaledent Inc Recall 87645

Description: 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

Coltene Whaledent Inc Recall 87645 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1494-2021
Event ID87645
Event DescriptionDental 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 TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of NJ, IN, NC, IL. GA, CA, NY, PA and the countries of Canada, Venezuela.
Quantity65 packs of 20 pins
Recall ReasonThe incorrect dental pins were packaged and subsequently distributed.
Device Classification20210505
Device Code InfoLot/Batch number: K39841
Center Classification Date20210426
Recall Initiation Date20210318
Recalling FirmColtene Whaledent Inc
Initial Notification Letter
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