Recall archive / FDA device enforcement
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation plat... — FDA record Z-0372-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 27, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Medacta Usa Inc
- Quantity
- 14 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0372-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Document Reference Code 99.81NEXTAR.12US (for US market only), Revision Numbers: Rev.02 and previous |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
AL, FL, NH, CO, IL, SC, AR
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 14, 2022
- Recall initiation date
- Oct 27, 2022
- Center classification date
- Dec 2, 2022
- Termination date
- Oct 23, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.