FDA-Device2023-07-26Class II
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
Materialise N.V.
Hazard
The wrong tibia guide was included intended for a different patient case.
Sold states
International Distribution to countries of: Germany, Netherlands
Affected count
2 Guides
Manufactured in
Technologielaan 15, N/A, Heverlee, N/A, Belgium
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2213-2023Don't want to check this manually?
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