Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1088-06 · Posted 2006-06-08

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeMAX
Date Initiated2006-01-14
Date Terminated2007-10-15
Product Quantity1 unit

Reason for Recall

Device distribution without marketing clearance

Firm Action

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

Root Cause

Other

Distribution Pattern

LA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051320SATELLITE SPINAL SYSTEMMedtronic Sofamor Danek · 2005-09-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑