# FDA recall Z-0372-2023

> **Medacta Usa Inc** · Class II · device recall initiated 2022-10-27.

## 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.

## Distribution

AL, FL, NH, CO, IL, SC, AR

## Key facts

- **Recall number:** Z-0372-2023
- **Recalling firm:** Medacta Usa Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-10-27
- **Report date:** 2022-12-14
- **Termination date:** 2023-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0372-2023

## Citation

> AI Analytics. FDA recall Z-0372-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0372-2023. Source: US FDA. Licensed CC0.

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