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
Recall
- Recall Number
- Z-1494-2021
- Event Number
- 87645
- Firm
- Coltene Whaledent Inc
- FEI Number
- 2416455
- Product Code
- EBL
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- March 18, 2021
- Address
- 235 Ascot Pkwy, Cuyahoga Falls, OH, 44223-3701
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
The incorrect dental pins were packaged and subsequently distributed.
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.
Worldwide distribution - US Nationwide distribution in the states of NJ, IN, NC, IL. GA, CA, NY, PA and the countries of Canada, Venezuela.
65 packs of 20 pins