FDAFDA · Food and drugs·Recall number Z-0809-2018
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Published March 7, 2018 · Recall initiated: September 21, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Aesculap Implant Systems LLC
- Distributor
- US Distribution to PA.
- Lot
- Batch #20034364 and #20034751
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States