# FDA recall Z-1485-2020

> **Materialise N.V.** · Class II · device recall initiated 2020-02-03.

## Product

TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013

## Reason for recall

Custom surgical kits contain a plate different than indicated by the package labeling.

## Distribution

US: NY.  OUS: Italy

## Key facts

- **Recall number:** Z-1485-2020
- **Recalling firm:** Materialise N.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-03
- **Report date:** 2020-03-25
- **Termination date:** 2020-03-20

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1485-2020

## Citation

> AI Analytics. FDA recall Z-1485-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1485-2020. Source: US FDA. Licensed CC0.

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