—#157746

Product

PALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0. 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.

FDA product code: MNI — Orthosis, Spinal Pedicle Fixation
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K140359
Affected lot / code info: Catalog No. 0902-1023. Known Lot No. WNV111118, WNV110819, WNV110720, WNV110725, WNV120802.

Why it was recalled

Devices are not consistent with Quality System Requirements.

Root cause (FDA determination)

Device Design

Action the firm took

Valorem Surgical sent an Urgent Medical Device Recall letter dated June 21, 2017, informing consignees of the product removal and instructing consignees to return any product to Valorem Surgical LLC to minimize potential risk to patients. Consignees are to fill out the attached Medical Device Recall Return Response form and send it back to the firm by email at global.safety@ValoremSurgical.com or by fax at 312-275-7117, or by mail. For questions pertaining to this recall, please submit an email inquiry to global.safety@ValoremSurgical.com

Recalling firm

Firm: Valorem Surgical LLC
Address: 3963 W Belmont Ave, Ste 9, Chicago, Illinois 60618-5129

Distribution

Distribution pattern: Nationwide Distribution - US including CA and VA.

Timeline

Recall initiated: 2017-06-21
Terminated: 2018-11-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157746. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.