New Era Orthopaedics, LLc: Medical Device Recall in 2018 - (Recall #: Z-2604-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 13, 2017

Date Posted: August 15, 2018

Recall Number: Z-2604-2018

Event ID: 80499

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.

Status: Terminated

Product Quantity: 6 pieces

Code Information:

11125

Distribution Pattern:

2 distributors in CO and TX.

Voluntary or Mandated:

Voluntary: Firm initiated