Food, drugs, devices › Aesculap Implant Systems LLC
Device recall: For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Aesculap Implant Systems LLC (Center Valley, PA) initiated this device recall on 20 Jul 2023; FDA lists 1 product record under event 92813, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Aesculap Implant Systems LLC has 35 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Aesculap Implant Systems LLC, Center Valley, PA.
Reason for recall
"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."
Distribution
"US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2518-2023 | For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R | 25 units | Class II | Ongoing | 13 Sep 2023 |
Context
Other enforcement events for Aesculap Implant Systems LLC
All 35 events for Aesculap Implant Systems LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.