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Recall Observatory FDA recall evidence

Device product

Genius Knee Cemented Tibial Component Product Usage: Knee replacement component

Z-0833-2019

December 10, 2018

Class II

Product summary

Firm
Signature Orthopedics Pty Limited
Event
Event 81967
Status
Terminated
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-0833-2019

Official wording

Reason: Product mix up

Code information: UDI # 09348215020309 Device Model # 121-07-4004 Lot # 77A3F

Distribution pattern: US Nationwide Distribution in the states of FL, NY, and TN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product mix up