The FDA has posted 33 enforcement recalls of metal/polymer cemented constrained femorotibial knee prosthesis devices since 2025, none of them Class I (most serious). Most recent report: Aug 19, 2026.
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted…
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer”). Informational only — verify against the FDA before acting.