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Synthes (USA), LLC

✅ Low Risk

FEI: 1719045 • Monument, CO • UNITED STATES

FEI

FEI Number

1719045

📍

Location

Monument, CO

🇺🇸
🏢

Address

1101 Synthes Ave, , Monument, CO, United States

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
4/24/2012
Latest Refusal
4/24/2012
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

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).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
4/24/2012
87HXZCUTTER, WIRE
118NOT LISTED
341REGISTERED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Synthes (USA), LLC's FDA import refusal history?

Synthes (USA), LLC (FEI: 1719045) has 1 FDA import refusal record(s) in our database, spanning from 4/24/2012 to 4/24/2012.

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. Synthes (USA), LLC's FEI number is 1719045.

What types of violations has Synthes (USA), LLC received?

Synthes (USA), LLC 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 Synthes (USA), LLC come from?

All FDA import refusal data for Synthes (USA), LLC 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.