Brasseler Steinmann Pin (Brasseler) – incorrect label (2019)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Brasseler USA I Lp
Lot Codes / Batch Numbers
Lot Number NR8ZR
Products Sold
Lot Number NR8ZR
Brasseler USA I Lp is recalling Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Pro due to 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 inco. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, FL
Page updated: Jan 10, 2026