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
Reported: May 5, 2021 Initiated: March 18, 2021 #Z-1494-2021
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.
Details
- Recalling Firm
- Coltene Whaledent Inc
- Units Affected
- 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.
- Location
- Cuyahoga Falls, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Coltene Whaledent Inc. Units affected: 65 packs of 20 pins.
Why was this product recalled? ▼
The incorrect dental pins were packaged and subsequently distributed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 5, 2021. Severity: Moderate. Recall number: Z-1494-2021.
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