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.
- 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
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.