Reported Oct 4, 2023 · Ongoing
exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental…
Exocad GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exocad GmbH · Julius-Reiber-Str. 37 · Darmstadt, N/A · N/A
Is this the product you have?
- 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 codes and dates
- 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
- Amount recalled
- 96 licenses
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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