Dutch inspectorate flags exocad exoplan field safety notice over implant drilling depth
IGJ has published a manufacturer warning for exocad's exoplan planning software after a dentist found one implant, sleeve and drill combination could drill 2.0 mm deeper than expected.
The Dutch Health and Youth Care Inspectorate (IGJ) has published a field safety notice (FSN) from exocad GmbH covering its exoplan dental implant planning software. The notice is dated 3 November 2026, and IGJ's page carries a date of 9 November 2026.
According to the inspectorate, one of exocad's official resellers reported a finding by a treating dentist. Using a specific combination of implant, sleeve and surgical drill can result in an osteotomy being drilled 2.0 mm deeper than expected. The source text does not name the implant, sleeve or drill involved.
IGJ says that during an internal review, a second finding was identified. The page does not describe the nature of that second finding. The full eight-page notice is available as an English-language PDF on the IGJ website.
IGJ notes that manufacturers must monitor their devices after they are placed on the market and improve them where necessary. Where a risk to users exists, they must act and inform users and the inspectorate through a field safety notice. The text does not set out the specific corrective actions, which are detailed in the manufacturer's notice.
What it means for your team
- Manufacturers and resellers should read the full exocad FSN to identify which implant, sleeve and drill combinations are affected and what corrective actions are required.
- Dental practices and clinicians using exoplan should check their planned cases against the notice, as the reported issue concerns drilling depth that is 2.0 mm greater than expected.
- Vigilance and quality teams should note that a second finding emerged from exocad's internal review and confirm whether it affects their own workflows.
- Teams should log the notice in their post-market surveillance and field safety corrective action records.
Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.
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