Dental pins — Class II medical device recall Z-1494-2021
Ongoing recall by Coltene Whaledent Inc, reported 2021-05-05, distributed nationwide. The incorrect dental pins were packaged and subsequently distributed.
| Recall number | Z-1494-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Coltene Whaledent Inc, Cuyahoga Falls, OH, United States |
| Recall initiated | 2021-03-18 |
| Classified | 2021-04-26 |
| Reported by FDA | 2021-05-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, VE |
| Lot numbers | K39841 |
| Model numbers | L741 |
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
Reason for recall
The incorrect dental pins were packaged and subsequently distributed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1494-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.