Recall Z-0834-2019— Signature Orthopedics Pty Limited

Name: FDA recall Z-0834-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-10

Class II · Terminated

Class II FDA medical device recall by Signature Orthopedics Pty Limited, initiated 2018-12-10, terminated 2020-12-14. It names one FDA 510(k) clearance: K170613. Product: Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component. Reason: Product mix up.

Recalling firm: Signature Orthopedics Pty Limited
Classification: Class II
Status: Terminated
Initiated: 2018-12-10
Terminated: 2020-12-14
Firm location: Lane Cove West, N/A, Australia

510(k) clearances named in this recall

1 on FDA's record

K170613 — Genius Total Knee SystemSignature Orthopaedics Pty, Ltd.·cleared 2017-07-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Product mix up

Data sourced from openFDA. This site is unofficial and independent of the FDA.