Z-1883-2018 Class II Terminated
FDA device recall Z-1883-2018 was initiated by Coltene Whaledent Inc on Apr 13, 2018 and is designated Class II. Reason for recall: The products are labeled with an incorrect product number. The recall status is terminated (terminated Apr 8, 2019). Affected quantity: 11.
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- Apr 13, 2018
- Termination Date
- Apr 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11
Product Description
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.
Distribution Pattern
The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada
Code Information
Batch I37640
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1883-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026