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Materialise N.V. recalls MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched dev
Recalled July 26, 2023 · FDA recall Z-2213-2023 · Materialise N.V
Hazard
The wrong tibia guide was included intended for a different patient case. · FDA Class II
Units
2 Guides
Sold at
International Distribution to countries of: Germany, Netherlands
Description
The wrong tibia guide was included intended for a different patient case.
Product
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
Manufacturer(s)
Materialise N.V.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →