Device 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.
Z-0884-2020
Product summary
- Event
- Event 84545
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56 packs of 6
- Official record key
device-enforcement:Z-0884-2020
Official wording
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 information: Lot Number NR8ZR
Distribution pattern: US: AZ, AR, FL
Derived failure modes
-
Labeling or packaging
incorrect product labels