Home / Recalls / Conformis, Inc. / Z-1108-2019

Z-1108-2019 Class II Terminated

Recalled by Conformis, Inc. — Billerica, MA

Recall Details

Product Type
Devices
Report Date
April 17, 2019
Initiation Date
December 3, 2018
Termination Date
June 26, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.

Reason for Recall

The kits were prepared with incorrect patient ID labels and may contain incorrect components.

Distribution Pattern

Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.

Code Information

Serial Numbers 0432428 and 0432212

Other recalls by Conformis, Inc.

  • Z-1569-2025 Class II — restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL- (March 25, 2025)
  • Z-1591-2024 Class II — Identity Imprint PS Tibial Tray Size 4: Lot 540287 (March 11, 2024)
  • Z-2405-2023 Class II — CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO (June 16, 2023)
  • Z-1133-2023 Class II — iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE (November 14, 2022)
  • Z-0899-2022 Class II — iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: (February 22, 2022)
  • Z-0475-2021 Class II — iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis (September 21, 2020)
  • Z-2849-2020 Class II — Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Imp (July 20, 2020)
  • Z-1627-2020 Class II — iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPO (February 3, 2020)
  • Z-1628-2020 Class II — iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPO (February 3, 2020)
  • Z-0672-2020 Class II — iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product U (October 25, 2019)