FDA-Device2020-02-05Class II

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.

Brasseler USA I Lp
Hazard

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.

Sold states
US: AZ, AR, FL
Affected count
56 packs of 6
Manufactured in
1 Brasseler Blvd, N/A, Savannah, GA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0884-2020

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