Brasseler Twist Drills Recalled Due to Incorrect Laser Etching
Brasseler USA is recalling 387 units of 3.5 mm twist drills that were incorrectly laser etched as 2.5 mm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a labeling error (incorrect diameter etching) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Brasseler USA I Lp is recalling one lot of 3.5 mm twist drills (Lot Number NR1VM). The recall involves 387 units of the KM166-310-35 Twist Drill Quick Connect, which are intended for use in drilling into bone during hip or knee surgeries.
The recall was initiated because the devices were incorrectly laser etched as 2.5 mm on the shaft, despite being 3.5 mm in diameter. This labeling error could lead to the use of the wrong size instrument during surgical procedures.
The affected products were distributed nationwide in the United States. Healthcare providers and facilities should stop using the affected lot and contact Brasseler USA for further instructions.
The recalled product
- 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.
- Manufacturer
- Brasseler USA I Lp
- Hazard
- Affected units
- 387
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number NR1VM
Distribution
Distributed nationwide across the United States.
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