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Valorem Surgical LLC recalls PALLAS M/MAXIMIS Persuader. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Produ
Recalled August 16, 2017 · FDA recall Z-3013-2017 · Valorem Surgical
Hazard
Devices are not consistent with Quality System Requirements. · FDA Class II
Units
262 units total
Sold at
Nationwide Distribution - US including CA and VA.
Description
Devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Persuader. 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.
Manufacturer(s)
Valorem Surgical LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →