Home / Recalls / Conformis, Inc. / Z-1591-2024

Z-1591-2024 Class II Ongoing

Recalled by Conformis, Inc. — Billerica, MA

Recall Details

Product Type
Devices
Report Date
April 24, 2024
Initiation Date
March 11, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Product Description

Identity Imprint PS Tibial Tray Size 4: Lot 540287

Reason for Recall

Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.

Distribution Pattern

US Nationwide distribution in the states of FL, KS and NH.

Code Information

Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287

Other recalls by Conformis, Inc.

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  • 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)