Official recall record

exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visuali

US FDA — Medical Devices · 2023-08-17 · GermanyClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-08-17
Country of alert: Germany
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 4260521365026
Brand on record: Exocad GmbH
Product category: Medical Device

What the authority reported

A software library filtering error has been discovered which occurs when users are using the Step-by-Step Full Drill Protocol export functionality of exoplan 3.1 Rijeka. When a guided surgery treatment approach is selected, along with a Step-by-Step Full Drill Protocol export implant library, exoplan software does not filter out unsupported sleeve height positions for a particular sub-full drill protocol and instead shows ALL possible sleeve height positions for all sub-full drill protocols. The use of an improper sleeve height position in a surgical guide could result in patient injury

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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