# FDA recall Z-0266-2018

> **Medacta Usa Inc** · Class II · device recall initiated 2017-10-24.

## Product

The GMK knee system:  designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges:  02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF

## Reason for recall

Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%.   For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.

## Distribution

nationwide

## Key facts

- **Recall number:** Z-0266-2018
- **Recalling firm:** Medacta Usa Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-24
- **Report date:** 2017-12-27
- **Termination date:** 2018-06-20

- **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-0266-2018

## Citation

> AI Analytics. FDA recall Z-0266-2018. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-0266-2018. Source: US FDA. Licensed CC0.

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