Recall Z-0372-2023— Medacta Usa Inc

Name: FDA recall Z-0372-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-27

Class II · Terminated

Class II FDA medical device recall by Medacta Usa Inc, initiated 2022-10-27, terminated 2023-10-23. It names one FDA 510(k) clearance: K210153. 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. Reason: 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..

Recalling firm: Medacta Usa Inc
Classification: Class II
Status: Terminated
Initiated: 2022-10-27
Terminated: 2023-10-23
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K210153 — NextAR RSA PlatformMedacta International S.A.·cleared 2021-05-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.