Home / Recalls / Conformis, Inc. / Z-0475-2021

Z-0475-2021 Class II Terminated

Recalled by Conformis, Inc. — Billerica, MA

Recall Details

Product Type
Devices
Report Date
December 2, 2020
Initiation Date
September 21, 2020
Termination Date
June 12, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.

Reason for Recall

Incorrect hip components were provided in kits.

Distribution Pattern

US Distribution in CA.

Code Information

Serial numbers 0469255, 0469255

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-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)
  • Z-0064-2020 Class II — iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Sp (August 22, 2019)