Home / Recalls / Conformis, Inc. / Z-0731-2019

Z-0731-2019 Class II Terminated

Recalled by Conformis, Inc. — Billerica, MA

Recall Details

Product Type
Devices
Report Date
January 23, 2019
Initiation Date
October 16, 2018
Termination Date
June 29, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101

Reason for Recall

The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.

Distribution Pattern

The products were distributed to the following US states: TN.

Code Information

Serial Number 0424647

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-1628-2020 Class II — iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPO (February 3, 2020)
  • Z-1627-2020 Class II — iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR 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)