2 results
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Sources: EU EUDAMED, US FDA
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Status: Completed
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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. Ref: KNM-ZB02-00-01
FDA Enforcement
Class II
·Completed·Materialise N.V.·July 26, 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. Ref: KNM-ZB02-00-01
FDA Recall
Completed
·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JWH·April 26, 2023