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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Sofamor Danek,Medtronic Sofamor Danek, Satellite Spinal System Instruments

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 Class 2 Recall
Medtronic Sofamor Danek,Medtronic Sofamor Danek, Satellite Spinal System Instruments
see related information
Date Posted December 22, 2007
Recall Status1 Terminated on August 18, 2009
Recall Number Z-0210-2008
Recall Event ID 44967
Premarket Notification
510(K) Number
K051320 
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Medtronic Sofamor Danek, 8 mm Trial, size 8 mm, Material Stainless Steel/Radel, quantity 1 each, Non-sterile, Rx only, REF 8004208, Manufactured at: Bartlett, Tennessee, USA
Code Information ALL LOTS to include: NM04H0021, NM04H0051, NM04H005Z, NM04H0321
Recalling Firm/
Manufacturer
Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis, Tennessee 38132-1719
For Additional Information Contact Bert Kelly
901-396-3133
Manufacturer Reason
for Recall
Marketed without approval: The surgical technique includes reference to an 8mm Trial and 8mm Curette, while the cleared -510 (k)- device only includes spheres between 9.5 and 19 mm.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action On September 12, 2007, the recalling firm's representatives were instructed by electronic mail to remove any manuals in the field and contact surgeons who have evaluated, implanted or been trained to implant the Satellite System and to collect any guides they may have on site. The sales representatives that have accounts where the Satellite product was shipped directly were mailed the information and instructed to hand deliver the 9/13/07, Urgent Device Recall notices to each consignees risk management office. The recall was then expanded on 10/31/2007, to include the surgical manual, the implants and associated instruments. The delivery of the second Urgent Device Recall Notices, dated 10/25/07, were handled in three ways: 1) The letter was delivered to all initial consignees that received satellite products along with a questionnaire (response card) to be completed by the Risk Manager or equivalent administrative function., 2) The letter without the questionnaire was sent directly to target surgeons who are known to have implanted or have been trained to implant Satellite Product 3) a field action confirmation form was sent to Sales Representative with surgeon customers that are receiving the recall communication. The form will be completed by the Sales Representative to confirm the surgeons have received the recall communication and have returned any of the surgical techniques and instruments.
Quantity in Commerce 148 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LXH and Original Applicant = MEDTRONIC SOFAMOR DANEK
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