Recall Z-1883-2018 ยท EJL Bur, Dental
Coltene Whaledent Inc
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.
| Date | May 14, 2018 (initiated Apr 13, 2018) |
| Status | Terminated |
| Reason | The products are labeled with an incorrect product number. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 11 |
| Distribution | The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.