Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack — Class II medical device recall Z-1883-2018
Terminated recall by Coltene Whaledent Inc, reported 2018-05-23, distributed in NY. The products are labeled with an incorrect product number.
| Recall number | Z-1883-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Coltene Whaledent Inc, Cuyahoga Falls, OH, United States |
| Recall initiated | 2018-04-13 |
| Classified | 2018-05-15 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2019-04-08 |
| Distributed | NY |
| Countries outside the US | CA |
| Quantity | 11 |
| Reason classes | labeling |
| Lot numbers | I37640 |
| Model numbers | R100702 |
Product
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
Reason for recall
The products are labeled with an incorrect product number.
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-1883-2018. 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.