Valorem Surgical LLC recalls PALLAS M/MAXIMIS Distractor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Produ…

Recall date

June 21, 2017

Source

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

Recall number

Z-2971-2017

FDA classification

Class II

Brand / firm

Valorem Surgical LLC

Sold / distributed

Nationwide Distribution - US including CA and VA.

Why it was recalled

Devices are not consistent with Quality System Requirements.

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

What was recalled

PALLAS M/MAXIMIS Distractor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.