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U.S. Department of Health and Human Services

Class 2 Device Recall MAXIMIS Pedicle Screw Spinal Fixation System

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  Class 2 Device Recall MAXIMIS Pedicle Screw Spinal Fixation System see related information
Date Initiated by Firm June 21, 2017
Create Date August 10, 2017
Recall Status1 Terminated 3 on November 27, 2018
Recall Number Z-2987-2017
Recall Event ID 77500
510(K)Number K140359  
Product Classification Orthosis, spinal pedicle fixation - Product Code MNI
Product PALLAS M/MAXIMIS Extension Block. 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.
Code Information Catalog No. 0902-1015; Known Lot No. WNV120723, WNV110331.
Recalling Firm/
Manufacturer		 Valorem Surgical LLC
3963 W Belmont Ave Ste 9
Chicago IL 60618-5129
For Additional Information Contact Joseph Jin
312-852-2700
Manufacturer Reason
for Recall		 Devices are not consistent with Quality System Requirements.
FDA Determined
Cause 2		 Device Design
Action 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
Quantity in Commerce 262 units total
Distribution Nationwide Distribution - US including CA and VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MNI and Original Applicant = VALOREM SURGICAL
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