MRI Biomet Pin Guide for Knee Surgery Shipped to Wrong Patient
Materialise N.V. is recalling MRI Biomet Pin Guides for total knee arthroplasty because the wrong patient-specific device was included in a shipment. Using an incompatible guide could affect surgical planning and implant placement.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall involving a risk-of-harm product (surgical-guide incompatibility that could affect implant placement). No illnesses, injuries, or deaths have been reported; the hazard remains theoretical at this time.
Plain-English summary
Materialise N.V. is recalling specific lots of MRI Biomet Pin Guides for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments, Reference KNM-ZB02-00-01) due to a manufacturing error in which the wrong patient's surgical guide was included in a shipment.
The MRI Biomet Pin Guide is a patient-matched medical device designed to fit each individual patient's unique anatomy. It is used to transfer a pre-operative surgical plan to the operating room during total knee replacement surgery. When the wrong patient's guide is used, it will not fit the intended patient's anatomy, potentially compromising the surgical plan and implant placement.
This recall affects shipments distributed to Germany and the Netherlands (Lot Numbers: ZB22UHINEF, ZB23MANOLA). Healthcare providers who received these devices should verify that the correct patient-specific guide is used for each procedure. If the wrong guide was used during surgery, the patient's surgical team should be contacted immediately for appropriate follow-up.
The recalled product
- 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
- Materialise N.V.
- Hazard
- surgical-device-mismatch
- implant-placement-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF
- ZB23MANOLA
Distribution
Distribution scope not specified by the agency.
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