New Era Orthopaedics, LLc recalls Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07

Recall date

February 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2604-2018

FDA classification

Class II

Brand / firm

New Era Orthopaedics, LLc

Sold / distributed

2 distributors in CO and TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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