Medtronic Sofamor Danek USA Inc 8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device-vertebral stabilization/fusion) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device-vertebral stabilization/fusion)
Brand
Medtronic Sofamor Danek USA Inc
Lot Codes / Batch Numbers
Cat No. 8000208, Lot No. W05K0555
Products Sold
Cat No. 8000208, Lot No. W05K0555
Medtronic Sofamor Danek USA Inc is recalling 8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device-vertebr due to Device distribution without marketing clearance. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device distribution without marketing clearance
Recommended Action
Per FDA guidance
The recalling firm sent out a letter notifying the implanting surgeon that he had implanted a device that was not approved for use.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
LA
Page updated: Jan 10, 2026