exoplan version 3 — Class II medical device recall Z-2633-2023

Ongoing recall by Exocad GmbH, reported 2023-10-04, distributed nationwide. A software library filtering error has been discovered which occurs when users are using the Step-by-Step Full

Recall number	`Z-2633-2023`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Exocad GmbH, Darmstadt, N/A, Germany
Recall initiated	2023-08-17
Classified	2023-09-25
Reported by FDA	2023-10-04
Distributed	Nationwide (US)
Countries outside the US	CA
Quantity	96 licenses
Reason classes	software
UPC / GTIN / UDI-DI	`04260521365026`

Product

exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2633-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.