FDA recall Z-0809-2018

Aesculap Implant Systems LLC · Class II · device

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0809-2018