Recall Z-0809-2018— Aesculap Implant Systems LLC

Name: FDA recall Z-0809-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-21

Class II · Terminated

Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2017-09-21, terminated 2018-08-08. It names one FDA 510(k) clearance: K161853. Product: proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components. Reason: A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure..

Recalling firm: Aesculap Implant Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2017-09-21
Terminated: 2018-08-08
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K161853 — proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt SystemAesculap, Inc.·cleared 2017-02-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.