—#65707

Product

Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 12 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000212, Manufactured at: Warsaw, Indiana, USA

FDA product code: NVR — Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: ALL LOTS to include: LX54, LX60, MA68, MG74, NB26, NE28, NF61

Why it was recalled

Labeling, including indications for use, lack 510 (K) approval

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Place, Memphis, Tennessee 38132-1719

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2007-09-13
Posted by FDA: 2007-12-22
Terminated: 2009-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #65707. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.