Recall Z-0372-2023 ยท OLO Orthopedic Stereotaxic Instrument
Medacta Usa Inc
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
| Date | Dec 3, 2022 (initiated Oct 27, 2022) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | Medacta issued an URGENT - Field Safety Notice to the surgeons on 10/28/2022 by email The notice provided the following information: "1. Description of advisory: The following 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 patie |
| Quantity | 14 units |
| Distribution | AL, FL, NH, CO, IL, SC, AR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210153 | NextAR RSA Platform Medacta International S.A., May 12, 2021 |