# FDA recall Z-0196-2019

> **Medacta Usa Inc** · Class II · device recall initiated 2017-11-15.

## Product

Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.

## Reason for recall

Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.

## Distribution

NC, ID, Belgium, Switzerland, Spain, Germany, Australia, France, Italy

## Key facts

- **Recall number:** Z-0196-2019
- **Recalling firm:** Medacta Usa Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-15
- **Report date:** 2018-10-31
- **Termination date:** 2019-03-29

- **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-0196-2019

## Citation

> AI Analytics. FDA recall Z-0196-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0196-2019. Source: US FDA. Licensed CC0.

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