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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92921

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 17, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Exocad GmbH

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2633-2023
Recall number
Z-2633-2023
Initiated
August 17, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exocad GmbH
Quantity
96 licenses

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software library filtering error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.