# FDA recall Z-2698-2020

> **Synthes, Inc.** · Class II · device recall initiated 2020-06-18.

## Product

MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.

## Reason for recall

One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.

## Distribution

International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.

## Key facts

- **Recall number:** Z-2698-2020
- **Recalling firm:** Synthes, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-18
- **Report date:** 2020-08-05
- **Termination date:** 2021-04-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2698-2020

## Citation

> AI Analytics. FDA recall Z-2698-2020. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-2698-2020. Source: US FDA. Licensed CC0.

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