| Class 2 Device Recall Medtronic Sofamor Danek, Satellite Spinal System Instruments | |
Date Initiated by Firm | September 13, 2007 |
Date Posted | December 22, 2007 |
Recall Status1 |
Terminated 3 on August 18, 2009 |
Recall Number | Z-0209-2008 |
Recall Event ID |
44967 |
Product Classification |
Spinal System - Product Code LXH
|
Product | Medtronic Sofamor Danek, 8 mm Curette, size 8 mm, Material Stainless Steel/Radel, quantity 1 each, Non-sterile, Rx only, REF 8003008, Manufactured at: Bartlett, Tennessee, USA |
Code Information |
ALL LOTS to include: NM04H015, NM04H015Z, NM04H031, NM04J023, NM04J0231 |
Recalling Firm/ Manufacturer |
Medtronic Sofamor Danek USA Inc 1800 Pyramid Place Memphis TN 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 | 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 | 347 units |
Distribution | Nationwide |
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.
|
|
|
|