proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Reported: March 7, 2018 Initiated: September 21, 2017 #Z-0809-2018
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.
Details
- Recalling Firm
- Aesculap Implant Systems LLC
- Units Affected
- 2
- Distribution
- US Distribution to PA.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components. Recalled by Aesculap Implant Systems LLC. Units affected: 2.
Why was this product recalled? ▼
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 7, 2018. Severity: Moderate. Recall number: Z-0809-2018.
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