# FDA recall Z-0809-2018

> **Aesculap Implant Systems LLC** · Class II · device recall initiated 2017-09-21.

## Product

proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System    Shunt, central nervous system and components

## Reason for recall

A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.

## Distribution

US Distribution to  PA.

## Key facts

- **Recall number:** Z-0809-2018
- **Recalling firm:** Aesculap Implant Systems LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-21
- **Report date:** 2018-03-07
- **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-0809-2018

## Citation

> AI Analytics. FDA recall Z-0809-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0809-2018. Source: US FDA. Licensed CC0.

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