Reported Sep 13, 2023 · Ongoing
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
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?
- For intraventricular indications mainly used for operations within the brain ventricles
- Product CodeFF399R
- Lot codes and dates
- UDI-DI04038653065547
- Lot Numbers
52750146 5275338152756472527683175280565552812596528165705282387852830872
- Serial Numbers
4281428242844288428942914308430943104312431343364340434143424402441144124413441444224439444744494450
- Amount recalled
- 25 units
Where it was sold
Why it was recalled
Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
This product could cause temporary or reversible health problems — stop using it.
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