FDA Device recall Z-2633-2023
exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visual…
- FDA Device
- Class II
- ongoing
- Published 2023-10-04
On 2023-10-04 the FDA classified a Class II recall of exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visual… by Exocad, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2633-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-17 |
| Published | 2023-10-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Exocad |
| Distribution | US |
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
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
Identifiers
| code_info | UDI-DI: (01)4260521365026(10)A03B01E8439 (US) (01)4260521365026(10)A03B01E8588 (SR1 US) (01)4260521365026(10)A03B01E86…UDI-DI: (01)4260521365026(10)A03B01E8439 (US) (01)4260521365026(10)A03B01E8588 (SR1 US) (01)4260521365026(10)A03B01E8606 (SR1 US offline) Software xoplan 3.1 Rijeka |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2633-2023%22
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