Medtronic Sofamor Danek USA, Inc
⚠️ High Risk
FEI: 3003120897 • Memphis, TN • UNITED STATES
FEI
FEI Number
3003120897
📍
Location
Memphis, TN
🇺🇸
Country
UNITED STATES🏢
Address
4340 Swinnea Rd Bldg B, , Memphis, TN, United States
High Risk
FDA Import Risk Assessment
59.5
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
308
Total Refusals
2
Unique Violations
2/11/2016
Latest Refusal
11/10/2014
Earliest Refusal
Score Breakdown
Violation Severity
54.5×40%
Refusal Volume
92.2×30%
Recency
0.0×20%
Frequency
100.0×10%
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
118285×
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
23751×
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87HXXSCREWDRIVER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87HXBPROBE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87HXBPROBE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87HWXTAP, BONE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87HWXTAP, BONE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Medtronic Sofamor Danek USA, Inc's FDA import refusal history?
Medtronic Sofamor Danek USA, Inc (FEI: 3003120897) has 308 FDA import refusal record(s) in our database, spanning from 11/10/2014 to 2/11/2016.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Medtronic Sofamor Danek USA, Inc's FEI number is 3003120897.
What types of violations has Medtronic Sofamor Danek USA, Inc received?
Medtronic Sofamor Danek USA, Inc has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Medtronic Sofamor Danek USA, Inc come from?
All FDA import refusal data for Medtronic Sofamor Danek USA, Inc is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.