# FDA recall Z-0591-2018

> **Aesculap Implant Systems LLC** · Class II · device recall initiated 2017-08-10.

## Product

NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468)    The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.

## Reason for recall

The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled.  If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and possible revision surgery.

## Distribution

USA (nationwide)

## Key facts

- **Recall number:** Z-0591-2018
- **Recalling firm:** Aesculap Implant Systems LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-10
- **Report date:** 2018-02-21
- **Termination date:** 2018-08-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0591-2018

## Citation

> AI Analytics. FDA recall Z-0591-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0591-2018. Source: US FDA. Licensed CC0.

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