Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the insert label and the pin label, the surgeon may implant the incorrect pin size.
Reason for recall: Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the insert label and the pin label, the surgeon may implant the incorrect pin size. Distribution: US: MN, IL, IN, NY, FL Quantity: 216 Lot/code info: REF/UDI-DI/Lot: 346-22-706/ 00190446219378/484V1013, 484V1014, 484V1015, 484V1016, 484V1017, 484V1018; 346-22-707/ 00190446219385/485V1001, 485V1002, 485V1003, 485V1004; 346-22-708/ 00190446219392/486V1005, 486V1006, 486V1007, 486V1008; 346-22-709/ 00190446219408/487V1001, 487V1002, 487V1003, 487V1004; 346-22-710/ 00190446219415/488V1003, 488V1004, 488V1005, 488V1006; 346-22-711/ 00190446219422/489V1003, 489V1004, 489V1005, 489V1006; 346-22-755/ 00190446219439/490V1001, 490V1002, 490V1003, 490V1004; 346-22-766/ 00190446219477/491V1002, 491V1003, 491V1004; 346-25-702/ 00190446219507/492V1002, 492V1003, 492V1004, 492V1005; 346-25-703/ 00190446219569/493V1001, 493V1002, 493V1003, 493V1004; 346-25-704/ 00190446219583/494V1001, 494V1002, 494V1003, 494V1004; 346-25-705/ 00190446219590/495V1001, 495V1002, 495V1003, 495V1004; 346-25-755/ 00190446219781/ 502V1001, 502V1002, 502V1003; 346-25-766/ 00190446219798/503V1003, 503V1004, 503V1005, 503V1006, 503V1007;
00190446219378, 00190446219385, 00190446219392, 00190446219408, 00190446219415, 00190446219422, 00190446219439, 00190446219477, 00190446219507, 00190446219569, 00190446219583, 00190446219590, 00190446219781, 00190446219798
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.