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U.S. Department of Health and Human Services

Class 2 Device Recall PEDICLE SCREW SYSTEM

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 Class 2 Device Recall PEDICLE SCREW SYSTEMsee related information
Date Initiated by FirmFebruary 20, 2013
Date PostedMay 27, 2013
Recall Status1 Terminated 3 on March 26, 2014
Recall NumberZ-1410-2013
Recall Event ID 64586
510(K)NumberK110633 
Product Classification Orthosis, spinal pedicle fixation - Product Code MNI
Product50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Code Information Item #BG7050
Recalling Firm/
Manufacturer		 Spinal Solutions, LLC
26157 Jefferson Ave
Murrieta CA 92562-9561
For Additional Information Contact
951-304-9001
Manufacturer Reason
for Recall		The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
FDA Determined
Cause 2		Labeling design
ActionSpinal Solutions sent a recall letter dated March 8, 2013 to all customers who purchased loaner bins and sterilization trays for implants and instruments from Spinal Solutions. The letter identified the affected product, problem identified and actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
Quantity in Commerce52 units
DistributionUSA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MNI
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