FDA Enforcement
Class II
Terminated
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.
Recall: Z-0884-2020
·
Reported February 5, 2020
Enforcement
- Recall Number
- Z-0884-2020
- Event ID
- 84545
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Brasseler USA I Lp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- February 5, 2020
- Initiation Date
- December 11, 2019
- Classification Date
- January 29, 2020
- Termination Date
- February 12, 2021
- Address
- 1 Brasseler Blvd, N/A, Savannah, GA, 31419-9576, United States
Description
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.
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.
Code Info
Lot Number NR8ZR
Distribution
US: AZ, AR, FL
Quantity
56 packs of 6