Home / Recalls / ConforMIS, Inc. / Z-0658-2017

Z-0658-2017 Class II Terminated

Recalled by ConforMIS, Inc. — Bedford, MA

Recall Details

Product Type: Devices
Report Date: December 7, 2016
Initiation Date: October 18, 2016
Termination Date: December 7, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 units

Product Description

ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.

Reason for Recall

Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.

Distribution Pattern

Distributed to the states of CO and NV.

Code Information

Serial Numbers: 0381024; 0381042 Exp Date: 2017-02-28

Other recalls by ConforMIS, Inc.

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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)