Conformis Inc. FDA Recalls

5 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Class IIMar 25, 2025The hip cup liner that was packaged with the incorrect label	The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 containe	Class IIDevices	Mar 25, 2025
Identity Imprint PS Tibial Tray Size 4: Lot 540287Class IIMar 11, 2024Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4	Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540	Class IIDevices	Mar 11, 2024
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EOClass IIJun 16, 202330mm screws were labeled as 25mm screws.	30mm screws were labeled as 25mm screws.	Class IIDevices	Jun 16, 2023
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AEClass IINov 14, 2022Loctite thread locker (epoxy) may not have been applied to t	Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absenc	Class IIDevices	Nov 14, 2022
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101Class IIFeb 22, 2022Incorrect tibial base plate implant packaged in kit	Incorrect tibial base plate implant packaged in kit	Class IIDevices	Feb 22, 2022