Recall Z-1008-2024 ยท EJL Bur, Dental
Brasseler USA I Lp
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
| Date | Feb 7, 2024 (initiated Jan 11, 2024) |
| Status | Open, Classified |
| Reason | The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters dated 1/8/2024 on 1/11/2024 via certified mail. The letter explains the reason for recall and required customer actions. The actions included that upon receipt of the letter, confirm the quantity of unused recalled product in their inventory and set it aside for return. Return information will be emailed to the consignee with a return label. The Customer Service emailed the letters to consignees on 1/12/2024 and sent product return instructions in the email. Phone calls will be made on 1/16/2024 if no response if received from the consignee via email. |
| Quantity | 440 burs |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, CA, CO, DC, IL, NY, OH, OR, PA, TN, TX, and WA. The country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.