proSA Tool Set used to adjust and verify the proSA recall
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Why was proSA Tool Set used to adjust and verify the proSA recalled?
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch #20034364 and #20034751
- Product
- proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 2
- Distribution
- US Distribution to PA.
- Recall date
- March 7, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)