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.
This recall has been terminated (originally issued October 18, 2019).
- Company
- Brasseler Usa I Lp
- Recall Initiated
- October 18, 2019
- Terminated
- December 14, 2020
- Recall Number
- Z-0591-2020
- Quantity
- 387 units
- Firm Location
- Savannah, GA
- Official Source
- View on FDA website ↗
Reason for Recall
One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.
Distribution
US Nationwide distribution.
Lot / Code Info
Lot Number NR1VM
Root Cause
Under Investigation by firm
Action Taken
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.