# FDA recall Z-0775-2020

> **Medacta Usa Inc** · Class II · device recall initiated 2019-11-04.

## Product

Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

## Reason for recall

Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.

## Distribution

US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH.

## Key facts

- **Recall number:** Z-0775-2020
- **Recalling firm:** Medacta Usa Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-04
- **Report date:** 2020-01-15
- **Termination date:** 2021-05-21

- **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-0775-2020

## Citation

> AI Analytics. FDA recall Z-0775-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0775-2020. Source: US FDA. Licensed CC0.

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