medical Class II Updated 2023-07-26

Materialise N.V. recalls MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Bio

Recalled 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


Hazard / Issue

The wrong tibia guide was included intended for a different patient case.

Issued by

FDA

Distribution: International Distribution to countries of: Germany, Netherlands
Lot/Code Info: UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA
View official government recall

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