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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1494-2021 |
| Event ID | 87645 |
| Event 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 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of NJ, IN, NC, IL. GA, CA, NY, PA and the countries of Canada, Venezuela. |
| Quantity | 65 packs of 20 pins |
| Recall Reason | The incorrect dental pins were packaged and subsequently distributed. |
| Device Classification | 20210505 |
| Device Code Info | Lot/Batch number: K39841 |
| Center Classification Date | 20210426 |
| Recall Initiation Date | 20210318 |
| Recalling Firm | Coltene Whaledent Inc |
| Initial Notification | Letter |
| Similar To |