NextAR Shoulder Surgical Technique — Class II medical device recall Z-0372-2023
Terminated recall by Medacta Usa Inc, reported 2022-12-14, distributed in AL, AR, CO, FL, IL, NH, SC. A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable pati
| Recall number | Z-0372-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medacta Usa Inc, Memphis, TN, United States |
| Recall initiated | 2022-10-27 |
| Classified | 2022-12-02 |
| Reported by FDA | 2022-12-14 |
| Terminated | 2023-10-23 |
| Distributed | AL, AR, CO, FL, IL, NH, SC |
| Quantity | 14 units |
| Reason classes | specification failure, device malfunction |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0372-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.