Recall Z-0464-2021 ยท EJL Bur, Dental
Coltene Whaledent Inc
Alpen Clinic 100 Carbide Instruments (R100057C)
| Date | Oct 20, 2020 |
| Status | Open, Classified |
| Reason | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. |
| Root cause | Under Investigation by firm |
| Action | On October 20, 2020, the firm emailed Urgent Medical Device Recall letters to affected distributors. Customers were informed that the incorrect dental carbide bur was manufactured and subsequently packaged and distributed. Customers were asked to return the product to Coltene/Whaledent, Inc. by following the instructions in the letter. The firm will replace the product at no cost. Please inform the firm if you have already used the product. Distributors were asked to either identify and notify their customers who were shipped the affected product or to provide a list of affected customers to |
| Quantity | 556 packs |
| Distribution | Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.