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.
This recall has been terminated (originally issued May 14, 2018).
- Company
- Coltene Whaledent Inc
- Recall Initiated
- April 13, 2018
- Posted
- May 14, 2018
- Terminated
- April 8, 2019
- Recall Number
- Z-1883-2018
- Quantity
- 11
- Firm Location
- Cuyahoga Falls, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The products are labeled with an incorrect product number.
Distribution
The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada
Lot / Code Info
Batch I37640
Root Cause
Under Investigation by firm
Action Taken
Customers were contacted via telephone call on 4/13/18. The customers were asked the following questions: 1. Confirm that {name of Distributor} received {number of packs} around this date {date}. 2. Confirm that the affected product, lot number I37460, is still in their inventory. a. If not, to whom was it shipped to? [Coltene will need that contact information]. 3. Can you take a picture of the lot number I37460 that you received and send to {Regional sales manager}? 4. Please return the product in question to Coltene per Vendor Return Authorization with full tracking information.