| Class 2 Device Recall Medtronic INTREPID Spinal System SPACER |  |
Date Initiated by Firm | February 06, 2009 |
Date Posted | July 24, 2009 |
Recall Status1 |
Terminated 3 on April 19, 2010 |
Recall Number | Z-1796-2009 |
Recall Event ID |
52125 |
510(K)Number | K080083 |
Product Classification |
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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Product | Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, REF 7961814; 16MM, REF 7961816; 18MM, REF 7961818; 20MM, REF 7961820; 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/ Manufacturer |
Medtronic Sofamor Danek USA Inc 1800 Pyramid Place Memphis TN 38132
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For Additional Information Contact | Marybeth Thorsgaard 901-396-1800 |
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.
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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 | 637 units |
Distribution | Worldwide Distribution -- United States, Australia, Germany, The Netherlands, and South Africa. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MAX
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