AllClear
PricingSign in
FDAFebruary 13, 2017device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

new era orthopaedics

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →