FDA Device recall Z-0591-2020
BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill i…
- FDA Device
- Class II
- terminated
- Published 2019-12-11
On 2019-12-11 the FDA classified a Class II recall of BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill i… by Brasseler Usa I, citing one lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0591-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-18 |
| Published | 2019-12-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Brasseler Usa I |
| Distribution | US |
Product
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
One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.
Identifiers
| code_info | Lot Number NR1VM |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0591-2020%22
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