Recall Z-2633-2023— Exocad GmbH

Name: FDA recall Z-2633-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-17

Class II · Ongoing

Class II FDA medical device recall by Exocad GmbH, initiated 2023-08-17. It names one FDA 510(k) clearance: K213302. 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.

Recalling firm: Exocad GmbH
Classification: Class II
Status: Ongoing
Initiated: 2023-08-17
Firm location: Darmstadt, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K213302 — exoplanExocad GmbH·cleared 2022-05-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.