Recall Z-1494-2021— Coltene Whaledent Inc
Class II · Ongoing
Class II FDA medical device recall by Coltene Whaledent Inc, initiated 2021-03-18. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: The incorrect dental pins were packaged and subsequently distributed..
- Recalling firm
- Coltene Whaledent Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-03-18
- Firm location
- Cuyahoga Falls, OH, United States
Product 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
Reason for recall
The incorrect dental pins were packaged and subsequently distributed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.