Total recalls 34 since 2012
Last 12 months 0 reported
Class I 0 0% of total
Ongoing 4 latest 23 Apr 2025
Recalls per month, last 24 months click a bar for that month Severity split
0 0%34 100%0 0%
Why conformis is recalled
Ongoing conformis recalls 4 active
All conformis recalls, newest first 34 total Reported Class Recall Company Reason Where 23 Apr 2025 Device CLASS II restor3d Cordera Hip System recalled by Conformis Conformis Labeling Errors Nationwide 24 Apr 2024 Device CLASS II Identity Imprint PS Tibial Tray Size recalled by Conformis Conformis Packaging Defects Nationwide 23 Aug 2023 Device CLASS II Hip-screw-, Sterile Eo recalled by Conformis Conformis Other Nationwide 22 Feb 2023 Device CLASS II iTotal Identity Impactor Handle recalled by Conformis Conformis Device Malfunction Nationwide 20 Apr 2022 Device CLASS II iTotal Identity Posterior Stabilised (PS) Knee Replacement System recalled Conformis Packaging Defects MS 2 Dec 2020 Device CLASS II iTotal Hip Replacement System recalled by Conformis Conformis Other CA 2 Sep 2020 Device CLASS II iTotal Cruciate Retaining (CR) Knee Replacement System recalled Conformis Other NV 8 Apr 2020 Device CLASS II iTotal CR Knee Replacement System recalled by Conformis Conformis Other Nationwide 8 Apr 2020 Device CLASS II iTotal PS Knee Replacement System recalled by Conformis Conformis Other Nationwide 18 Dec 2019 Device CLASS II iTotal CR Knee Replacement System recalled by Conformis Conformis Other Nationwide 16 Oct 2019 Device CLASS II iTotal Hip Replacement System recalled by Conformis Conformis Packaging Defects MD, NV 16 Oct 2019 Device CLASS II iTotal Hip Replacement System recalled by Conformis Conformis Packaging Defects MD, NV 19 Jun 2019 Device CLASS II iTotal Hip Replacement System: Hbs-033-00xx recalled by Conformis Conformis Other Nationwide 19 Jun 2019 Device CLASS II iTotal Hip Replacement System: Hbs-033-00xx recalled by Conformis Conformis Other Nationwide 17 Apr 2019 Device CLASS II iTotal CR Total Knee Replacement System, TCR-121-1111 recalled Conformis Other Nationwide 10 Apr 2019 Device CLASS II iTotal Posterior Stabilized (PS) Knee Replacement System recalled Conformis Sterility NH 23 Jan 2019 Device CLASS II iTotal Hip Replacement System, Total Hip Replacement System recalled Conformis Other TN 21 Feb 2018 Device CLASS II Total Knee Replacement recalled by ConforMIS ConforMIS Labeling Errors CA, TX 18 Jan 2017 Device CLASS II Itotal Ps-ipolyimplant Kit-right recalled by ConforMIS ConforMIS Other TX 7 Dec 2016 Device CLASS II iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile recalled ConforMIS Labeling Errors CO, NV 16 Mar 2016 Device CLASS II iTotal Cruciate Retaining (CR) Knee Replacement System recalled ConforMIS Other KY 28 Oct 2015 Device CLASS II iDUO G2, Right Lateral recalled by ConforMIS ConforMIS Other Nationwide 28 Oct 2015 Device CLASS II Unicondylar Knee Replacement System iUNI G2, Left Medial recalled ConforMIS Other Nationwide 28 Oct 2015 Device CLASS II iTotal CR Knee Replacement System- Itotal CR - Ipoly recalled ConforMIS Other Nationwide 28 Oct 2015 Device CLASS II iTotal CR (Cruciate Retaining) Knee Replacement recalled by ConforMIS ConforMIS Other Nationwide 28 Oct 2015 Device CLASS II iTotal Posterior Stabilized Knee Replacement System- Itotal recalled ConforMIS Other Nationwide 28 Oct 2015 Device CLASS II iDuo Knee Bicompartmental Knee Replacement System , iDUO G2 recalled ConforMIS Other Nationwide 28 Oct 2015 Device CLASS II iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral recalled ConforMIS Other Nationwide 28 Oct 2015 Device CLASS II iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral recalled ConforMIS Other Nationwide 28 Oct 2015 Device CLASS II iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial recalled ConforMIS Other Nationwide
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About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.