PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: December 14, 2022 Initiated: October 27, 2022 #Z-0372-2023

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Medacta Usa Inc
Units Affected
14 units
Distribution
AL, FL, NH, CO, IL, SC, AR
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
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. Recalled by Medacta Usa Inc. Units affected: 14 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 14, 2022. Severity: Moderate. Recall number: Z-0372-2023.