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Recall Observatory FDA recall evidence

Device product

GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis

Z-2883-2018

August 01, 2017

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 80752
Status
Terminated
Classification
Class II
Quantity
27 units
Official record key
device-enforcement:Z-2883-2018

Official wording

Reason: Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.

Code information: Lot Numbers: 16CMB0061A, 16CMB0066A

Distribution pattern: Australia, Austria, Germany, Great Britain, Poland, Spain

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.