exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visu...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2633-2023.
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
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2633-2023.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Exocad Gmbh or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2633-2023.
Exocad GmbH
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Exocad Gmbh Recall FAQ
Exocad Gmbh is the subject of a medical implants safety report: exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visu.... The notice was published on August 17, 2023 by the U.S. Food and Drug Administration (FDA). Approximately 96 units are potentially affected.