50 results
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45ms
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Sources: EU EUDAMED, US FDA
Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·November 14, 2012
TOTAL KNEE
FDA Adverse Event
Injury
·MEDACTA USA, INC.·Product code JWH·October 4, 2018
QUADRA C CEMENTED STEM SIZE 3 STD
FDA Adverse Event
Other
·MEDACTA USA INC.·Product code LZO·April 12, 2013
MY KNEE FEMUR CUTTING BLOCK #5 RIGHT MEDIAL
FDA Adverse Event
MEDACTA USA INC.·Product code LXH·February 21, 2014
QUADRA S FEMORAL CEMENTLESS STEM
FDA Adverse Event
Injury
·MEDACTA USA INC.·Product code JDI·April 8, 2013
AMIS BROACH HANDLE
FDA Adverse Event
MEDACTA USA INC.·Product code LZO·June 12, 2013
NEXTAR AUGMENTED REALITY NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA USA, INC.·Product code OLO·February 23, 2024
MEDACTA RIGHT KNEE REPLACEMENT
FDA Adverse Event
Injury
·MEDACTA USA, INC.·Product code JWH·April 14, 2025
MEDACTA RIGHT KNEE REPLACEMENT
FDA Adverse Event
Injury
·MEDACTA USA, INC.·Product code KRO·April 14, 2025
EVOLIS CEMENTED TIBAL BASE PLATE SIZE 2
FDA Adverse Event
Injury
·MEDACTA USA INC.·Product code JWH·July 17, 2013
AMISTEM H FEMORAL CEMENTLESS STEM SIZW 4 LAT
FDA Adverse Event
MEDACTA USA INC.·Product code LZO·July 18, 2013
QUADRA H CEMENTLESS STEM SIZE 3 LAT SHORT NECK
FDA Adverse Event
Injury
·MEDACTA USA INC.·Product code LZO·July 26, 2013
GMK PRIMARY FIXED CEMENTED FEMUR SIZE 5 LEFT
FDA Adverse Event
Injury
·MEDACTA USA INC.·Product code JWH·July 18, 2013
GMK EFFICIENCY SPHERE GENERAL SET
FDA Adverse Event
Malfunction
·MEDACTA USA, INC.·Product code LXH·March 18, 2020
Evolis-Femoral Sizer Posterior Reference The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The femoral sizer is an alternate instrument that can be used in addition to the standard MIS femoral sizer. The Femoral Sizer Posterior Reference intended to be placed on the distal femoral cut and determine the trail size and set the external rotation in preparation for the cut blocks. The femoral sizer posterior reference is intended to be placed on the distal femoral cut and determine the trial size and set the external rotation in preparation for the cut blocks. Indications for Use for the Medacta Evolis Total Knee System are: The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis - Avascular necrosis of femoral condyle - Post traumatic loss of joint configuration - Primary implantation failure.
FDA Recall
Terminated
·Medacta Usa Inc·Product code JWH·September 11, 2009
Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
FDA Recall
Terminated
·Medacta Usa Inc·Product code JDI·October 13, 2008
Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
FDA Recall
Terminated
·Medacta Usa Inc·Product code LZO·November 15, 2017
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
FDA Recall
Terminated
·Medacta Usa Inc·Product code KRO·May 19, 2017
Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
FDA Recall
Terminated
·Medacta Usa Inc·Product code KWS·November 4, 2019
MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
FDA Recall
Completed
·Medacta Usa Inc·Product code OVD·March 8, 2023