Home / Recalls / Conformis, Inc. / Z-2849-2020

Z-2849-2020 Class II Terminated

Recalled by Conformis, Inc. — Billerica, MA

Recall Details

Product Type
Devices
Report Date
September 2, 2020
Initiation Date
July 20, 2020
Termination Date
June 21, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 kit

Product Description

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

Reason for Recall

Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920

Distribution Pattern

NV

Code Information

Serial Number: 0469247 Exp. 2021-01-31

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-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)