Brasseler USA I Lp recalls BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product…
- Recall date
- October 18, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0591-2020
- FDA classification
- Class II
- Brand / firm
- Brasseler USA I Lp
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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