FDA Recall
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
·
Initiated December 11, 2019
Recall
- Recall Number
- Z-0884-2020
- Event Number
- 84545
- Firm
- Brasseler USA I Lp
- FEI Number
- 3004949275
- Product Code
- HTY
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- December 11, 2019
- Terminated
- February 12, 2021
- Address
- 1 Brasseler Blvd, Savannah, GA, 31419-9576
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.
Action
Initial contact to affected consignees was made on 12/11/2019 by telephone to provide notification of the labeling error and arrange for replacement product. Recall letter also sent to affected consignees.
Distribution
US: AZ, AR, FL
Quantity
56 packs of 6