Home / Recalls / Conformis, Inc. / Z-2405-2023

Z-2405-2023 Class II Ongoing

Recalled by Conformis, Inc. — Billerica, MA

Recall Details

Product Type
Devices
Report Date
August 23, 2023
Initiation Date
June 16, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25 units

Product Description

CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO

Reason for Recall

30mm screws were labeled as 25mm screws.

Distribution Pattern

US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.

Code Information

Model No. HAA-030-0625-000101; UDI-DI: M572HAA0300625011; Lot No. 1232071.

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-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)
  • Z-0063-2020 Class II — iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Sp (August 22, 2019)