# FDA recall Z-2633-2023

> **Exocad GmbH** · Class II · device recall initiated 2023-08-17.

## 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

## Distribution

Worldwide distribution - US Nationwide and the country of Canada.

## Key facts

- **Recall number:** Z-2633-2023
- **Recalling firm:** Exocad GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-17
- **Report date:** 2023-10-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Darmstadt, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2633-2023

## Citation

> AI Analytics. FDA recall Z-2633-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2633-2023. Source: US FDA. Licensed CC0.

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