# FDA recall Z-1247-2022

> **Medacta Usa Inc** · Class II · device recall initiated 2022-04-13.

## Product

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

## Reason for recall

A Size 2 trial baseplate was assembled with Size 1 instrument sets.

## Distribution

Distribution was made to AK, CA, CT, IN, MA, NJ, and PA.  There was no foreign/military/government distribution.

## Key facts

- **Recall number:** Z-1247-2022
- **Recalling firm:** Medacta Usa Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-04-13
- **Report date:** 2022-06-15
- **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-1247-2022

## Citation

> AI Analytics. FDA recall Z-1247-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1247-2022. Source: US FDA. Licensed CC0.

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