Z-0372-2023 Class II Terminated
FDA device recall Z-0372-2023 was initiated by Medacta Usa Inc on October 27, 2022 and is designated Class II. 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 f… The recall status is terminated (terminated October 23, 2023). Affected quantity: 14 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 14, 2022
- Initiation Date
- October 27, 2022
- Termination Date
- October 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
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.
Distribution Pattern
AL, FL, NH, CO, IL, SC, AR
Code Information
Document Reference Code 99.81NEXTAR.12US (for US market only), Revision Numbers: Rev.02 and previous