# FDA recall Z-2399-2021

> **DePuy Orthopaedics, Inc.** · Class II · device recall initiated 2021-08-10.

## Product

TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting  Part Number: 420916

## Reason for recall

Software:  A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.

## Distribution

Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.

## Key facts

- **Recall number:** Z-2399-2021
- **Recalling firm:** DePuy Orthopaedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-10
- **Report date:** 2021-09-08
- **Termination date:** 2023-05-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2399-2021

## Citation

> AI Analytics. FDA recall Z-2399-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2399-2021. Source: US FDA. Licensed CC0.

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