The FDA has posted 31 enforcement recalls of metal/polymer cemented constrained femorotibial knee prosthesis devices since 2025, none of them Class I (most serious). Most recent report: Jul 8, 2026.
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.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
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.