Z-0591-2020 Class II Terminated
FDA device recall Z-0591-2020 was initiated by Brasseler USA I Lp on October 18, 2019 and is designated Class II. Reason for recall: One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device. The recall status is terminated (terminated December 14, 2020). Affected quantity: 387 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2019
- Initiation Date
- October 18, 2019
- Termination Date
- December 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 387 units
Product Description
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.
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 Pattern
US Nationwide distribution.
Code Information
Lot Number NR1VM