FDAOctober 25, 2019device
iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR 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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
What to do
FDA enforcement status: Terminated
Brands named
conformis
UPCs
1111111010102
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDArestor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System2025-03-25
- FDAIdentity Imprint PS Tibial Tray Size 4: Lot 5402872024-03-11
- FDACONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO2023-06-16
- FDAiTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE2022-11-14
- FDAiTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-0201012022-02-22
- FDAiTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.2020-09-21
- FDAConformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)2020-07-20
- FDAiTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR 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 addresse...2020-02-03
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