Home / Recalls / New Era Orthopaedics, LLc / Z-2604-2018

Z-2604-2018 Class II Terminated

Recalled by New Era Orthopaedics, LLc — Hummelstown, PA

Recall Details

Product Type: Devices
Report Date: August 15, 2018
Initiation Date: February 13, 2017
Termination Date: November 7, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6 pieces

Product Description

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 Pattern

2 distributors in CO and TX.

Code Information

11125