Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 4, 2023
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.
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 gu…
Exocad GmbH recalled exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-oper… - a moderate-severity action.
exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-oper… was recalled by Exocad GmbH in October 4, 2023. Reason: A software library filtering error has been discovered which occurs when users are using the Step-by-Step Ful…. Check the official notice for the remedy. Verify recall #Z-2633-2023 with the FDA Devices before acting.
The recall
Exocad GmbH issued this moderate-severity FDA Devices recall-A software library filtering error has been discovered which occurs when users are using the Step-by-Step Ful….
- Moderate
- severity level
- Class II
- classification
- October 4, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2633-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2633-2023) was formally reported on October 4, 2023, with the manufacturer initiating the action on August 17, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Exocad GmbH is listed as the recalling firm, operating out of Darmstadt, N/A. Federal records list the affected scope as 96 licenses.
The documented reason for this recall is: 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 selec… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the country of Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
96 licenses
Related Recalls
6
3 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2633-2023 |
| Date reported | October 4, 2023 |
| Date initiated | August 17, 2023 |
| Recalling firm | Exocad GmbH |
| Firm location | Darmstadt, N/A |
| Affected scope | 96 licenses |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2633-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Exocad GmbH. Units affected: 96 licenses.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 4, 2023. Severity: Moderate. Recall number: Z-2633-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the country of Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2633-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 4, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.