# FDA recall Z-2213-2023

> **Materialise N.V.** · Class II · device recall initiated 2023-04-26.

## 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 for recall

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

## Distribution

International Distribution to countries of: Germany, Netherlands

## Key facts

- **Recall number:** Z-2213-2023
- **Recalling firm:** Materialise N.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-04-26
- **Report date:** 2023-07-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Heverlee, N/A, Belgium

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2213-2023

## Citation

> AI Analytics. FDA recall Z-2213-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2213-2023. Source: US FDA. Licensed CC0.

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