# FDA recall Z-2604-2018

> **New Era Orthopaedics, LLc** · Class II · device recall initiated 2017-02-13.

## Product

Modera Modular Pedicle Screw System   Shank Insertion Instrument, 3-107-07

## Reason for recall

This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which excessive forces were applied to the shank insertion instrument and the laser weld failed.

## Distribution

2 distributors in CO and TX.

## Key facts

- **Recall number:** Z-2604-2018
- **Recalling firm:** New Era Orthopaedics, LLc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-02-13
- **Report date:** 2018-08-15
- **Termination date:** 2018-11-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2604-2018

## Citation

> AI Analytics. FDA recall Z-2604-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2604-2018. Source: US FDA. Licensed CC0.

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