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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic INTREPID Spinal System SPACER

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  Class 2 Device Recall Medtronic INTREPID Spinal System SPACER see related information
Date Initiated by Firm February 06, 2009
Date Posted July 24, 2009
Recall Status1 Terminated 3 on April 19, 2010
Recall Number Z-1799-2009
Recall Event ID 52125
510(K)Number K080083  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product Medtronic INTREPID Spinal System SPACER M 37X27, 12 DEG, Size: 10MM, Part Number: REF 7962210; 12MM, REF 7962212; 14MM, REF 7962214; 16MM, REF 7962216; 18MM, REF 7962218; 20MM, REF 7962220; USA, Rx only, STERILE R.

The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.
Code Information All Lots.
Recalling Firm/
Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132
For Additional Information Contact Marybeth Thorsgaard
Manufacturer Reason
for Recall
The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
FDA Determined
Cause 2
Device Design
Action Medtronic Sofamor Danek USA, Inc. instructed Sales Representative on starting February 6, 2009 by phone to immediately return product from the field. The firm further issued a "Subject: Medtronic Intrepid Intervertebral Body Fusion Device Recall" notice dated April 2009. The recall notices were mailed directly to Risk Managers and Surgeons, with Recall Questionnaires and Surgeon Confirmation forms included respectively. For further questions, contact your Medtronic Sales Representative or the Medtronic Global Quality Department at 1-800-876-3133 extension 6333.
Quantity in Commerce 711 units
Distribution Worldwide Distribution -- United States, Australia, Germany, The Netherlands, 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 = MAX and Original Applicant = MEDTRONIC SOFAMOR DANEK