Recall archive / FDA device enforcement
MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched ... — FDA record Z-2213-2023
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 26, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- The wrong tibia guide was included intended for a different patient case.
- Classification
- Class II
- Recalling firm
- Materialise N.V.
- Quantity
- 2 Guides
- Agency-reported status
- Completed
- Source record identifier
- Z-2213-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International Distribution to countries of: Germany, Netherlands
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 26, 2023
- Recall initiation date
- Apr 26, 2023
- Center classification date
- Jul 20, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.