Savannah, GA, United States
Brasseler USA I Lp recalls
3 recalls recorded since 2018, most recently on 11 January 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 11 January 2024
- Reason
- The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, CA, CO, DC, IL, NY, OH, OR, PA, TN, TX, and WA. The country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1008-2024
- Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Terminated Class II Medical devices
- Recall started
- 11 December 2019
- Terminated
- 12 February 2021
- Reason
- 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.
- Distribution
- US: AZ, AR, FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0884-2020
- 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.
Terminated Class II Medical devices
- Recall started
- 18 October 2019
- Terminated
- 14 December 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0591-2020
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.