Recall Z-1694-2021— Signature Orthopedics Pty Limited

Name: FDA recall Z-1694-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-20

Class II · Terminated

Class II FDA medical device recall by Signature Orthopedics Pty Limited, initiated 2021-04-20, terminated 2023-01-19. It names one FDA 510(k) clearance: K121297. Product: Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.. Reason: Product mislabeled, with the incorrect product inside the package..

Recalling firm: Signature Orthopedics Pty Limited
Classification: Class II
Status: Terminated
Initiated: 2021-04-20
Terminated: 2023-01-19
Firm location: Lane Cove West, Australia

510(k) clearances named in this recall

1 on FDA's record

K121297 — ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULARSignature Orthopaedics Pty, Ltd.·cleared 2012-12-28

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

Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.

Reason for recall

Product mislabeled, with the incorrect product inside the package.

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