Devices

Device Recall MAXIMIS Pedicle Screw Spinal Fixation System.

Model / Serial
Catalog No. P375-040; Known Lot No. WNV120328 & WNV110525.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution - US including CA and VA.
Product Description
PALLAS M/MAXIMIS Poly Screw 7.5 x 40mm. 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
Valorem Surgical LLC
1 Event
- Recall of Device Recall MAXIMIS Pedicle Screw Spinal Fixation System.

Manufacturer

Valorem Surgical LLC

Manufacturer Address
Valorem Surgical LLC, 3963 W Belmont Ave Ste 9, Chicago IL 60618-5129
Source
USFDA

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