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U.S. Department of Health and Human Services

Class 2 Device Recall TSRH(R) Spinal System SCREW

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  Class 2 Device Recall TSRH(R) Spinal System SCREW see related information
Date Initiated by Firm July 12, 2011
Date Posted August 19, 2011
Recall Status1 Terminated 3 on July 20, 2012
Recall Number Z-3044-2011
Recall Event ID 59375
510(K)Number K984522  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
Product TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx only, QTY: 1 EA, Medtronic Sofamor Danek USA.

Product Usage: TSRH(R) Spinal System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the thoracic, lumber, and/or sacral spine.
Code Information Lot number 0149857W
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132
For Additional Information Contact Marybeth Thorsgaard
901-396-1800
Manufacturer Reason
for Recall		 Screws are 5 mm longer than the size etched on the screw.
FDA Determined
Cause 2		 Error in labeling
Action On 07/12/2011, the recalling firm, Medtronic notified the Sales Managers and Sales Force by conference call and email regarding the imminent notification and follow-up activities. A "VOLUNTARY RECALL" notification letter was sent to Risk Managers and Sales Representatives on 07/13/2011 with a delivery date of 07/14/2011. The letter states to immediately remove the recalled product from use and return to Medtronic. The letter includes a questionnaires form to be completed and returned as per the instructions. If appropriate, personal follow up with Sales Representatives will be made to assure that Risk Managers understand the recall communication and to facilitate return of product and the associated questionnaire documentation. For questions, contact your Medtronic Sales Representative or the Global Quality Department at 800-876-3133, extension 3173.
Quantity in Commerce 17 units
Distribution Nationwide Distribution (USA) including the states of: OH, NY, and WI
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 = KWP and Original Applicant = DANEK MEDICAL, INC.
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