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.

Recall Insight

This FDA Devices action (record #Z-1883-2018) was formally reported on May 23, 2018, with the manufacturer initiating the action on April 13, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Coltene Whaledent Inc is listed as the recalling firm, operating out of Cuyahoga Falls, OH. Federal records indicate 11 units are affected.

The documented reason for this recall is: The products are labeled with an incorrect product number. Distribution data in the federal record shows the product reached: The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.