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Aesculap Implant Systems LLC recalls proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and componen
Recalled March 7, 2018 · FDA recall Z-0809-2018 · Aesculap Implant Systems
Hazard
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure. · FDA Class II
Units
2
Sold at
US Distribution to PA.
Description
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Product
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Manufacturer(s)
Aesculap Implant Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →