Medacta Usa Inc: Medical Device Recall in 2022 - (Recall #: Z-0372-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: October 27, 2022

Date Posted: December 14, 2022

Recall Number: Z-0372-2023

Event ID: 91091

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.

Status: Terminated

Product Quantity: 14 units

Code Information:

Document Reference Code 99.81NEXTAR.12US (for US market only), Revision Numbers: Rev.02 and previous

Distribution Pattern:

AL, FL, NH, CO, IL, SC, AR

Voluntary or Mandated:

Voluntary: Firm initiated