FDAClass IIFebruary 20, 2019

Genius Knee Cemented CR Femoral Component Product recall

Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component

Why was Genius Knee Cemented CR Femoral Component Product recalled?

Product mix up

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI # 09348215020330 Device Model # 121-07-3000 Lot # 788F7-1

Product
Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
Recalling firm
Signature Orthopedics Pty Limited
Quantity
3
Distribution
US Nationwide Distribution in the states of FL, NY, and TN
Recall date
February 20, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls