Lower riskMedical device recall · FDA · Published April 13, 2018
Coltene Whaledent Alpen Carbide 702 Burs: Incorrect Product Number Label
Coltene Whaledent recalls Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 packs (Model R100702) due to incorrect product labeling. This may cause confusion in dental procedures.
“Coltene Whaledent Alpen Carbide 702 Burs: Incorrect Product Number Label.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71400-coltene-whaledent-alpen-carbide-702-burs-incorrect-product-number-label. Based on FDA recall #Z-1883-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1883-2018%22&limit=1).
Coltene Whaledent Inc voluntarily recalled Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702, because the products are labeled with an incorrect product number, according to the FDA. The recall was announced on April 13, 2018.
The products are labeled with an incorrect product number, according to the FDA.
Context
GovInfoNow's records show Coltene Whaledent Inc has issued five other recalls since August 21, 2018. Other recent recalls of similar products include Smith & Nephew BIOSURE HA Screw Recall (November 24, 2025), XTANT Medical Xpress Pedicle Screw System (February 18, 2026), and Medline TRACH TUBE KIT Recall (July 10, 2026).
How to tell if you have this one
Check for the model number R100702 on the packaging. The product was sold with batch number I37640.
Brand
Coltene Whaledent
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the model number R100702 and batch number I37640 on the packaging.
Where it went and when
Where it was distributed
Distributed in New York, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1883-2018 (April 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1883-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.