FDA-Device2022-12-14Class II
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
Medacta Usa Inc
Hazard
A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.
Sold states
AL, FL, NH, CO, IL, SC, AR
Affected count
14 units
Manufactured in
3973 Delp St, N/A, Memphis, TN, United States
Products
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0372-2023Don't want to check this manually?
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