Recall Z-0591-2020 ยท GFF Bur, Surgical, General & Plastic Surgery
Brasseler USA I Lp
BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.
| Date | Oct 18, 2019 |
| Status | Terminated |
| Reason | One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device. |
| Root cause | Under Investigation by firm |
| Action | Initial contact to customers was by telephone and visit on 18 October 2019. The firm followed with a letter disseminated by email on 10/25/2019. The firm is seeking return of the affected units and will replace them with correct devices. |
| Quantity | 387 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K872475 | SURGICAL BUR Tava Surgical Instruments, Jul 2, 1987 |