# FDA recall Z-0591-2020

> **Brasseler USA I Lp** · Class II · device recall initiated 2019-10-18.

## 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 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.

## Key facts

- **Recall number:** Z-0591-2020
- **Recalling firm:** Brasseler USA I Lp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-18
- **Report date:** 2019-12-11
- **Termination date:** 2020-12-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Savannah, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0591-2020

## Citation

> AI Analytics. FDA recall Z-0591-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0591-2020. Source: US FDA. Licensed CC0.

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