RecallRadar

FDA Device recall Z-1883-2018

Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tung…

On 2018-05-23 the FDA classified a Class II recall of Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tung… by Coltene Whaledent, citing the products are labeled with an incorrect product number.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1883-2018
ClassificationClass II
Statusterminated
Initiated2018-04-13
Published2018-05-23
Last updated2026-09-13 11:54 UTC
CompanyColtene Whaledent
DistributionNY

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

The products are labeled with an incorrect product number.

Identifiers

code_infoBatch I37640

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1883-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.