Conformis, Inc.
FDA adverse event reports naming Conformis, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: CONFORMIS, INC..
- Total reports
- 2,096
- Deaths
- 0
- Injuries
- 1,880
- Malfunctions
- 210
Reports per year
Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH1,716
- Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerHSX119
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH67
- Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/PolymerNPJ59
- Orthopedic Manual Surgical InstrumentLXH47
- Knee Arthroplasty Implantation SystemOOG38
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOIY24
- Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)HSH22
- ImpactorHWA2
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH1
Recent recalls
- 2025-04-15Open, ClassifiedLabeling Change Control
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
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.
- 2024-04-17Open, ClassifiedProcess design
Identity Imprint PS Tibial Tray Size 4: Lot 540287
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.
- 2023-08-16Open, ClassifiedError in labeling
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
30mm screws were labeled as 25mm screws.
- 2023-02-13Open, ClassifiedProcess control
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
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.
- 2017-01-10TerminatedSoftware Design Change
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal PS Knee Replacement System is 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 that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
- 2015-10-21TerminatedProcess design
ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
May contain small amounts of ethylene glycol residue
- 2015-10-21TerminatedProcess design
ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)
May contain small amounts of ethylene glycol residue
- 2015-10-21TerminatedProcess design
ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)
May contain small amounts of ethylene glycol residue
- 2015-10-21TerminatedProcess design
ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
May contain small amounts of ethylene glycol residue
- 2015-10-21TerminatedProcess design
ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
May contain small amounts of ethylene glycol residue
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