Brasseler USA I

3 recalls •

• Categories: Other Medical Devices, Diagnostic Equipment, Implants & Prosthetics

Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.

Class I - Dangerous

The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.

Jan 11, 2024 Other Medical Devices Nationwide View Details →

Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.

Class I - Dangerous

103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins.

Dec 11, 2019 Diagnostic Equipment View Details →

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.

Class I - Dangerous

One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.

Oct 18, 2019 Implants & Prosthetics Nationwide View Details →