Reported Dec 11, 2019 · Terminated
BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product…
Brasseler USA I LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Brasseler USA I Lp · 1 Brasseler Blvd · Savannah, GA · 31419-9576
Is this the product you have?
- BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm -
- Product UsageTwist
- drill intended useto drill into bone in hip or knee surgeries
- Lot codes and dates
- Lot Number NR1VM
- Amount recalled
- 387 units
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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