FDA recall Z-2604-2018

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

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

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