---
title: "MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Speci... — FDA record Z-2213-2023 | Is It on Recall"
description: "The wrong tibia guide was included intended for a different patient case."
url: https://isitonrecall.com/recall/fda-device-z-2213-2023-mri-biomet-pin-guide-for-total-knee-arthroplasty-zimmer-biomet-patient-specific-instruments-psi-pati/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2213-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2213-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Materialise N.V. records](https://isitonrecall.com/brand/materialise-n-v/)