Device 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
Z-1494-2021
Product summary
- Event
- Event 87645
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 65 packs of 20 pins
- Official record key
device-enforcement:Z-1494-2021
Official wording
Reason: The incorrect dental pins were packaged and subsequently distributed.
Code information: Lot/Batch number: K39841
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.
Derived failure modes
-
Unknown
The incorrect dental pins were packaged and subsequently distributed.