Reported Mar 7, 2018 · Terminated
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Aesculap Implant Systems LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aesculap Implant Systems LLC · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217
Is this the product you have?
- proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
- Lot codes and dates
- Batch #20034364 and #20034751
- Amount recalled
- 2
Where it was sold
Why it was recalled
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
This product could cause temporary or reversible health problems — stop using it.
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