exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implan
Summary
The FDA issued a Class II for exoplan version 3.1 Rijeka Software -A medical software, intended to support the by Exocad GmbH. 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 .
Details
Source
Device Recall
External ID
Z-2633-2023
Action Date
2023-10-04
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 96 licenses
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-17
Company
Darmstadt, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Exocad GmbH has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Exocad GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Exocad GmbH have FDA actions?
Exocad GmbH has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2633-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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