Product Wiki · Recalls · U.S. FDA — Device Enforcement

proSA Tool Set used to adjust and verify the proSA Adjustable Shunt… — recall Z-0809-2018

U.S. FDA — Device Enforcement · United States · 2017-09-21 · Class II

As described by U.S. FDA — Device Enforcement: proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0809-2018
Date of alert
2017-09-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Aesculap Implant Systems LLC
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Distribution to PA.
Reported risk: A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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