Medacta Usa Inc

FDA Regulatory Profile

Summary

Total Recalls
19
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1402-2023Class IIMectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion deviceMarch 8, 2023
Z-1403-2023Class IIMectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion deviceMarch 8, 2023
Z-1405-2023Class IIMectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion deviceMarch 8, 2023
Z-1400-2023Class IIMectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion deviceMarch 8, 2023
Z-1401-2023Class IIMectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion deviceMarch 8, 2023
Z-1404-2023Class IIMectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion deviceMarch 8, 2023
Z-0372-2023Class IINextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgicaOctober 27, 2022
Z-1247-2022Class IIGMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1April 13, 2022
Z-0775-2020Class IIMedacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes November 4, 2019
Z-0196-2019Class IIMedacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partNovember 15, 2017
Z-0266-2018Class IIThe GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary InserOctober 24, 2017
Z-2661-2017Class IIMedacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EOMay 19, 2017
Z-1023-2017Class IIMedacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat December 7, 2016
Z-0275-2016Class IIGMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic SurgeryApril 17, 2015
Z-0225-2015Class IIThe MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinOctober 21, 2014
Z-0202-2015Class IIGMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee rSeptember 22, 2014
Z-0791-2013Class IIMedacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip ProsthesiDecember 17, 2012
Z-0878-2013Class IIVersafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.013January 15, 2010
Z-0267-2013Class IIQuadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of dOctober 13, 2008