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Medacta Usa Inc recalls NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platfor
Recalled December 14, 2022 · FDA recall Z-0372-2023 · Medacta Usa
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. · FDA Class II
Units
14 units
Sold at
AL, FL, NH, CO, IL, SC, AR
Description
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.
Product
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
Manufacturer(s)
Medacta Usa Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →