Aesculap Implant Systems LLC recalls proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
- Recall date
- September 21, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0809-2018
- FDA classification
- Class II
- Brand / firm
- Aesculap Implant Systems LLC
- Sold / distributed
- US Distribution to PA.
Why it was recalled
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Get recall alerts
Free email alert whenever Aesculap Implant Systems LLC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Aesculap Implant Systems LLC