Brand
Materialise N.V.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Materialise N.V. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-08-09FDA-DeviceClass IIProPlan 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
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
- 2023-07-26FDA-DeviceClass IIMRI 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. Ref: KNM-ZB02-00-01
The wrong tibia guide was included intended for a different patient case.
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