Materialise recalls MRI Biomet Pin Guides for Total Knee Arthroplasty due to risk of wrong tibia guide being included for different patient cases. Affected patients should contact for remedy.
The wrong tibia guide was included intended for a different patient case.
Materialise is recalling MRI Biomet Pin Guides for Total Knee Ar: the wrong tibia guide may be included for a different patient case. This could lead to incorrect surgical planning and potential complications during knee replacement surgery.
The recall is for the wrong tibia guide being included in the package intended for a different patient case. This could lead to incorrect surgical planning during knee replacement procedures, potentially causing complications or errors in the surgery.
Patients who have received the MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments) are affected. Surgeons and surgical teams using these guides are at highest risk.
Check for the product code KNM-ZB02-00-01 or UDI-DI (01)05420060310027 on the packaging. The lot numbers ZB22UHINEF and ZB23MANOLA are also associated with this recall.
Reach out to Materialise N.V. for guidance on the recall and to determine if your specific product is affected.
The recall is because the wrong tibia guide was included in the package intended for a different patient case, which could lead to incorrect surgical planning during knee replacement procedures.
Contact Materialise N.V. to determine if your specific product is affected and to get guidance on the next steps.
Check for the product code KNM-ZB02-00-01 or UDI-DI (01)05420060310027 on the packaging. The lot numbers ZB22UHINEF and ZB23MANOLA are also associated with this recall.
We’ve drafted a message you can send Materialise to request your refund or repair — edit it as you like.
Subject: Recall Z-2213-2023 — Materialise Materialise Hello, I own a Materialise that is covered by recall Z-2213-2023 from Materialise. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
