Conformis, Inc.
Billerica, MA
This page shows every FDA and USDA recall linked to Conformis, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
16
Total Recalls
2018
First Recall
2024
Most Recent
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Apr 17, 2024
· Device
Open, Classified
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Aug 16, 2023
· Device
Open, Classified
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Feb 13, 2023
· Device
Open, Classified
iTotal Identity Posterior Stabilised (PS) Knee Replacement System
Model Number: TPS-301-1113-020101
Feb 22, 2022
· Device
Completed
iTotal Hip Replacement System, Model number HAA-050-D020-020102
The Conformis Hip System includes standard...
Sep 21, 2020
· Device
Terminated
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant
Cat: TCR-121-1111-010102...
Jul 20, 2020
· Device
Terminated
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product U...
Feb 3, 2020
· Device
Terminated
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Prod...
Feb 3, 2020
· Device
Terminated
iTotal CR Knee Replacement System
Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replac...
Oct 25, 2019
· Device
Terminated
iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Aug 22, 2019
· Device
Terminated
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Aug 22, 2019
· Device
Terminated
Conformis iTotal Hip Replacement System:
HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Mar 29, 2019
· Device
Terminated
Conformis iTotal Hip Replacement System:
HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Mar 29, 2019
· Device
Terminated
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Jan 4, 2019
· Device
Terminated
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.)
M5725INT...
Dec 3, 2018
· Device
Terminated
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Oct 16, 2018
· Device
Terminated