Z-1494-2021 Class II Ongoing
FDA device recall Z-1494-2021 was initiated by Coltene Whaledent Inc on Mar 18, 2021 and is designated Class II. Reason for recall: The incorrect dental pins were packaged and subsequently distributed. The recall status is ongoing. Affected quantity: 65 packs of 20 pins.
Recall Details
- Product Type
- Devices
- Report Date
- May 5, 2021
- Initiation Date
- Mar 18, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65 packs of 20 pins
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.
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.
Code Information
Lot/Batch number: K39841
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1494-2021
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026