Materialise N.V.
Materialise N.V. appears in FDA public data with 7 recalls, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2287-2023, Class II) was initiated on June 19, 2023.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2287-2023 | Class II | ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone | June 19, 2023 |
| Z-2213-2023 | Class II | MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- | April 26, 2023 |
| Z-2886-2020 | Class II | Match Point System The Match Point System is intended to by uses as a surgical instrument to assi | July 17, 2020 |
| Z-1485-2020 | Class II | TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013 | February 3, 2020 |
| Z-1484-2020 | Class II | TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 | February 3, 2020 |
| Z-0162-2016 | Class II | Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surg | September 23, 2015 |
| Z-1287-2015 | Class II | Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides ar | February 4, 2015 |