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Genius Knee Cemented Tibial Component Product Usage: Knee replacement component

FDA Recall #Z-0833-2019 — Class II — December 10, 2018

Recall #Z-0833-2019 Date: December 10, 2018 Classification: Class II Status: Terminated

Product Description

Genius Knee Cemented Tibial Component Product Usage: Knee replacement component

Reason for Recall

Product mix up

Recalling Firm

Signature Orthopedics Pty Limited — Lane Cove West, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

10

Distribution

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

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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