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.
This recall has been terminated (originally issued December 11, 2019).
- Company
- Brasseler Usa I Lp
- Recall Initiated
- December 11, 2019
- Terminated
- February 12, 2021
- Recall Number
- Z-0884-2020
- Quantity
- 56 packs of 6
- Firm Location
- Savannah, GA
- Official Source
- View on FDA website ↗
Reason for Recall
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
Lot / Code Info
Lot Number NR8ZR
Root Cause
Labeling mix-ups
Action Taken
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.