Home / Recalls / Signature Orthopedics Pty Limited / Z-0834-2019

Z-0834-2019 Class II Terminated

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

FDA device recall Z-0834-2019 was initiated by Signature Orthopedics Pty Limited on December 10, 2018 and is designated Class II. Reason for recall: Product mix up The recall status is terminated (terminated December 14, 2020). Affected quantity: 3.

Recall Details

Product Type
Devices
Report Date
February 20, 2019
Initiation Date
December 10, 2018
Termination Date
December 14, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3

Product Description

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

Reason for Recall

Product mix up

Distribution Pattern

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

Code Information

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

Other recalls by Signature Orthopedics Pty Limited

  • Z-1694-2021 Class II — Logical cup liner - Product Usage: intended to replace a hip joint where bone st (April 20, 2021)
  • Z-0833-2019 Class II — Genius Knee Cemented Tibial Component Product Usage: Knee replacement compon (December 10, 2018)
  • Z-0920-2018 Class II — Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature cerami (February 2, 2018)

FDA data resources