The FDA has posted 6 enforcement recalls of polymer/metal/polymer cemented semi-constrained patellofemorotibial knee prosthesis devices since 2025, none of them Class I (most serious). Most recent report: Sep 23, 2026.
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years.…
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Due to packaging discrepancy with incorrect product size mixed up.
Due to packaging discrepancy with incorrect product size mixed up.
Knee and Humeral socket implants contain incorrect labeling.
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay t…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer”). Informational only — verify against the FDA before acting.