Recall Z-2937-2020 ยท EJL Bur, Dental
Hager & Meisinger Gmbh
SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.
| Date | Jul 15, 2020 |
| Status | Terminated |
| Reason | US-dates between the product package label and the bar code display. |
| Root cause | Process control |
| Action | The US firm sent a recall letter to the affected consignees on 07/15/2020. On 07/23/2020 an UPDATED CUSTOMER NOTIFICATION - MEDICAL DEVICE RECALL letter with customer response form was sent to the consignees by US Mail. |
| Quantity | 144 units |
| Distribution | US Nationwide distribution including in the states of AZ, CA, FL, IN, NY, PA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.