Conformis Recalls
34 recalls on record · August 29, 2012 to April 23, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 23, 2025Medical DevicesFDA
Conformis Inc. recalls restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for
Hazard: The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
April 24, 2024Medical DevicesFDA
Conformis, Inc. recalls Identity Imprint PS Tibial Tray Size 4: Lot 540287
Hazard: 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.
August 23, 2023Medical DevicesFDA
Conformis, Inc. recalls CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Hazard: 30mm screws were labeled as 25mm screws.
February 22, 2023Medical DevicesFDA
Conformis, Inc. recalls iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Hazard: Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.
April 20, 2022Medical DevicesFDA
Conformis, Inc. recalls iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Hazard: Incorrect tibial base plate implant packaged in kit
December 2, 2020Medical DevicesFDA
Conformis, Inc. recalls iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replac
Hazard: Incorrect hip components were provided in kits.
September 2, 2020Medical DevicesFDA
Conformis, Inc. recalls Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL
Hazard: Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
April 8, 2020Medical DevicesFDA
Conformis, Inc. recalls iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The
Hazard: A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
April 8, 2020Medical DevicesFDA
Conformis, Inc. recalls iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage:
Hazard: A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
December 18, 2019Medical DevicesFDA
Conformis, Inc. recalls iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement Sys
Hazard: Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
October 16, 2019Medical DevicesFDA
Conformis, Inc. recalls iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Hazard: Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
October 16, 2019Medical DevicesFDA
Conformis, Inc. recalls iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Hazard: Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
June 19, 2019Medical DevicesFDA
Conformis, Inc. recalls Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Hazard: Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
June 19, 2019Medical DevicesFDA
Conformis, Inc. recalls Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Hazard: Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
April 17, 2019Medical DevicesFDA
Conformis, Inc. recalls iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (
Hazard: The kits were prepared with incorrect patient ID labels and may contain incorrect components.
April 10, 2019Medical DevicesFDA
Conformis, Inc. recalls iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Hazard: The labeling of the boxes and sterile pouches did not match the contents.
January 23, 2019Medical DevicesFDA
Conformis, Inc. recalls iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Hazard: The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
February 21, 2018Medical DevicesFDA
ConforMIS, Inc. recalls Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021
Hazard: Implant kit mislabeled
January 18, 2017Medical DevicesFDA
ConforMIS, Inc. recalls ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is inte
Hazard: iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
December 7, 2016Medical DevicesFDA
ConforMIS, Inc. recalls ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for
Hazard: Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
March 16, 2016Medical DevicesFDA
ConforMIS, Inc. recalls Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Hazard: Incorrect femoral component distributed
October 28, 2015Medical DevicesFDA
ConforMIS, Inc. recalls ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240
Hazard: May contain small amounts of ethylene glycol residue
October 28, 2015Medical DevicesFDA
ConforMIS, Inc. recalls ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY
Hazard: May contain small amounts of ethylene glycol residue
October 28, 2015Medical DevicesFDA
ConforMIS, Inc. recalls ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US)
Hazard: May contain small amounts of ethylene glycol residue
October 28, 2015Medical DevicesFDA
ConforMIS, Inc. recalls ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US)
Hazard: May contain small amounts of ethylene glycol residue
October 28, 2015Medical DevicesFDA
ConforMIS, Inc. recalls ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMP
Hazard: May contain small amounts of ethylene glycol residue
October 28, 2015Medical DevicesFDA
ConforMIS, Inc. recalls ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US)
Hazard: May contain small amounts of ethylene glycol residue
October 28, 2015Medical DevicesFDA
ConforMIS, Inc. recalls ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
Hazard: May contain small amounts of ethylene glycol residue
October 28, 2015Medical DevicesFDA
ConforMIS, Inc. recalls ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US)
Hazard: May contain small amounts of ethylene glycol residue
October 28, 2015Medical DevicesFDA
ConforMIS, Inc. recalls ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US)
Hazard: May contain small amounts of ethylene glycol residue