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Conformis Inc.

21 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-0 recall (Z-1569-2025)Conformis Inc.2025-04-15
Identity Imprint PS Tibial Tray Size 4: Lot 540287 recall (Z-1591-2024)Conformis, Inc.2024-04-17
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO recall (Z-2405-2023)Conformis, Inc.2023-08-16
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE recall (Z-1133-2023)Conformis, Inc.2023-02-13
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal PS Knee recall (Z-0991-2017)ConforMIS, Inc.2017-01-10
ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: recall (Z-0138-2016)ConforMIS, Inc.2015-10-21
ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M572206 recall (Z-0139-2016)ConforMIS, Inc.2015-10-21
ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: recall (Z-0140-2016)ConforMIS, Inc.2015-10-21
ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M recall (Z-0141-2016)ConforMIS, Inc.2015-10-21
ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Numbe recall (Z-0142-2016)ConforMIS, Inc.2015-10-21
ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalo recall (Z-0143-2016)ConforMIS, Inc.2015-10-21
ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - recall (Z-0144-2016)ConforMIS, Inc.2015-10-21
ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Cata recall (Z-0145-2016)ConforMIS, Inc.2015-10-21
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M572506 recall (Z-0146-2016)ConforMIS, Inc.2015-10-21
ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KI recall (Z-0147-2016)ConforMIS, Inc.2015-10-21
ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS recall (Z-0148-2016)ConforMIS, Inc.2015-10-21
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for recall (Z-0581-2015)ConforMIS, Inc.2014-12-11
Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 recall (Z-2222-2012)Conformis Inc2012-08-17
ConforMIS iUni ( Unicondylar Knee System ) Left Medial Implant Kit Product Code: M57220600 recall (Z-1622-2009)Conformis Inc2009-07-15
ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit Product Code : M5 recall (Z-1623-2009)Conformis Inc2009-07-15
ConforMIS iUni ( Unicondylar Knee System iUni Right Lateral Implant Kit Product Code: M572 recall (Z-1624-2009)Conformis Inc2009-07-15

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