Aesculap Implant Systems LLC: Medical Device Recall in 2018 - (Recall #: Z-0809-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 21, 2017

Date Posted: March 7, 2018

Recall Number: Z-0809-2018

Event ID: 79093

Reason for Recall:

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

Status: Terminated

Product Quantity: 2

Code Information:

Batch #20034364 and #20034751

Distribution Pattern:

US Distribution to PA.

Voluntary or Mandated:

Voluntary: Firm initiated