# FDA recall Z-2661-2017

> **Medacta Usa Inc** · Class II · device recall initiated 2017-05-19.

## Product

Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

## Reason for recall

One lot of product does not include a screw for attachment to the tibial base  plate.

## Distribution

CA, AZ, NC, Israel, France

## Key facts

- **Recall number:** Z-2661-2017
- **Recalling firm:** Medacta Usa Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-19
- **Report date:** 2017-07-12
- **Termination date:** 2018-05-29

- **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-2661-2017

## Citation

> AI Analytics. FDA recall Z-2661-2017. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-2661-2017. Source: US FDA. Licensed CC0.

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