Heverlee, N/A, Belgium
Materialise N.V. recalls
4 recalls recorded since 2018, most recently on 19 June 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 19 June 2023
- Reason
- Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
- Distribution
- US Nationwide distribution in the state of KY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2287-2023
- ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
Completed Class II Medical devices
- Recall started
- 26 April 2023
- Reason
- The wrong tibia guide was included intended for a different patient case.
- Distribution
- International Distribution to countries of: Germany, Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2213-2023
- MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR
Terminated Class II Medical devices
- Recall started
- 17 July 2020
- Terminated
- 23 December 2020
- Reason
- The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.
- Distribution
- Nationwide distribution to: US including PR and International to UK and Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2886-2020
- Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referenc
Terminated Class II Medical devices
- Recall started
- 3 February 2020
- Terminated
- 20 March 2020
- Reason
- Custom surgical kits contain a plate different than indicated by the package labeling.
- Distribution
- US: NY. OUS: Italy
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1484-2020, Z-1485-2020
- TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
- TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.