—#45681

Product

8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device-vertebral stabilization/fusion)

FDA product code: MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051320
Affected lot / code info: Cat No. 8000208, Lot No. W05K0555

Why it was recalled

Device distribution without marketing clearance

Root cause (FDA determination)

Other

Action the firm took

The recalling firm sent out a letter notifying the implanting surgeon that he had implanted a device that was not approved for use.

Recalling firm

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

Distribution

Distribution pattern: LA

Timeline

Recall initiated: 2006-01-14
Posted by FDA: 2006-06-08
Terminated: 2007-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45681. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.