FDAClass IIJuly 26, 2023

MRI Biomet Pin Guide for Total Knee Arthroplasty recall

MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the…

Why was MRI Biomet Pin Guide for Total Knee Arthroplasty recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA

Product
MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the…
Recalling firm
Materialise N.V.
Quantity
2 Guides
Distribution
International Distribution to countries of: Germany, Netherlands
Recall date
July 26, 2023
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls