FDA-Device2017-08-16Class II
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.
Valorem Surgical LLC
Hazard
Devices are not consistent with Quality System Requirements.
Sold states
Nationwide Distribution - US including CA and VA.
Affected count
262 units total
Manufactured in
3963 W Belmont Ave Ste 9, N/A, Chicago, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2971-2017Don't want to check this manually?
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