Materialise N.V recalls

2 official recalls and safety alerts involving Materialise N.V since 2023-07, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Materialise N.V or the relevant agency.

1. 2023-08-09
2. US
   Drugs & medicalClass II

   Materialise N.V. recalls ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in…

   Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

   FDA · DeviceMaterialise N.V.US Nationwide distribution in the state of KY.Official notice →
3. 2023-07-26
4. US
   Drugs & medicalClass II

   Materialise N.V. recalls MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to…

   The wrong tibia guide was included intended for a different patient case.

   FDA · DeviceMaterialise N.V.International Distribution to countries of: Germany, NetherlandsOfficial notice →