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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Navigated Solera Screwdrivers

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  Class 2 Device Recall Medtronic Navigated Solera Screwdrivers see related information
Date Initiated by Firm September 14, 2015
Date Posted September 30, 2015
Recall Status1 Terminated 3 on December 03, 2015
Recall Number Z-2824-2015
Recall Event ID 72183
510(K)Number K050438  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLERA REDUCTION.
The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.
Code Information For this action, device lot numbers are not applicable. The action covers all lots of products distributed between September 2010 and July 2015
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact Mr. Michael Blasco
800-595-9709 Ext. 3303
Manufacturer Reason
for Recall		 Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
FDA Determined
Cause 2		 Labeling design
Action Medtronic sent an Urgent Medical Device Correction Notification letter dated September 14, 2015, to all affected consignees via FedEx. Revised Instructions for Use were provided to add additional warnings related to the careful inspection of the instruments and the importance of knowledge of operating procedures, patient selection, and product information. Consignees with questions were instructed to to call the local Medtronic Navigation Technical Services Representative or call 1-800-995-9709.
Quantity in Commerce 2346
Distribution Worldwide Distribution - US (nationwide) and Internationally to Canada; United Arab Emirates; Australia; Belgium; Switzerland; China; Germany; Denmark; Spain; Finland; France; Great Britain; Greece; India; Israel; Italy; Japan; Netherlands; New Zealand; Poland; Portugal; Sweden; Singapore; Thailand; Slovakia; Turkey; and South Africa.
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 = HAW and Original Applicant = MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
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