Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PALLAS M/MAXIMIS Driver Shaft (5Hex Recalled by Valorem Surgical LLC Due to Devices are not consistent with Quality System Requirements.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Valorem Surgical LLC directly.
Affected Products
PALLAS M/MAXIMIS Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. 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.
Quantity: 262 units total
Why Was This Recalled?
Devices are not consistent with Quality System Requirements.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Valorem Surgical LLC
Valorem Surgical LLC has 144 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report