Conformis recalls
5 official recalls and safety alerts involving Conformis since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Conformis or the relevant agency.
- 2025-04-23
USConformis Inc. recalls 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.
FDA · DeviceConformis Inc.US Nationwide distribution in the states of CA, FL, NV, TN.Official notice →- 2024-04-24
- US
Conformis, Inc. recalls 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.
FDA · DeviceConformis, Inc.US Nationwide distribution in the states of FL, KS and NH.Official notice → - 2023-08-23
- US
Conformis, Inc. recalls CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
30mm screws were labeled as 25mm screws.
FDA · DeviceConformis, Inc.US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, &…Official notice → - 2023-02-22
- US
Conformis, Inc. recalls 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.
FDA · DeviceConformis, Inc.US Nationwide distribution in the states of AL, AZ, CO, FL, GA, KS, KY, LA,…Official notice → - 2022-04-20
- US
Conformis, Inc. recalls iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Incorrect tibial base plate implant packaged in kit