CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report
Alpen Carbide 702 Cross Cut Tapered Fissure FG (Carbide Burs) recalled
Coltene Whaledent is recalling Alpen Carbide 702 Cross Cut Tapered Fissure FG (Carbide Burs), distributed in New York. The recall was initiated on 13 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1883-2018
- FDA event ID
- 79994
- Recalling firm
- Coltene Whaledent, Cuyahoga Falls, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2018
- FDA classified
- 15 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 13 Apr 2018 | Recall initiated by company | |
| 15 May 2018 | Classified by FDA | +32 days |
| 23 May 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The products are labeled with an incorrect product number.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada
Questions about this recall
Why was it recalled?
The products are labeled with an incorrect product number.
Which lots are affected?
Batch I37640
Where was it sold?
The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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