EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE...
FDA Recall #Z-1187-2023 — Class II — December 22, 2022
Product Description
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 9, 22MM, REF: 346-22-709; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 10, 22MM, REF: 346-22-710; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 11, 22MM, REF: 346-22-711; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 5 BRIDGE UP, 22MM, REF: 346-22-755; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6 BRIDGE DOWN, 22MM, REF: 346-22-766; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 2, 25MM, REF: 346-25-702; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 3, 25MM, REF: 346-25-703; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 4, 25MM, REF: 346-25-704; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 5, 25MM, REF: 346-25-705; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 5 BRIDGE UP, 25MM, REF: 346-25-755; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6 BRIDGE DOWN, 25MM, REF: 346-25-766
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.
Recalling Firm
Encore Medical, LP — Austin, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
216
Distribution
US: MN, IL, IN, NY, FL
Code Information
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;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated