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Recall Observatory FDA recall evidence

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

December 11, 2019

Class II

Product summary

Firm
Brasseler USA I Lp
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

    reason.labeling_packaging · v1.0.0

    incorrect product labels