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Fh Orthopedics

⚠️ Moderate Risk

FEI: 3006356426 • Heimsbrunn, Haut Rhin • FRANCE

FEI

FEI Number

3006356426

📍

Location

Heimsbrunn, Haut Rhin

🇫🇷

Country

FRANCE
🏢

Address

3 rue de la Foret, , Heimsbrunn, Haut Rhin, France

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

11
Total Refusals
2
Unique Violations
8/19/2013
Latest Refusal
8/23/2011
Earliest Refusal

Score Breakdown

Violation Severity
46.9×40%
Refusal Volume
40.0×30%
Recency
0.0×20%
Frequency
55.2×10%
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

11811×

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).

3412×

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
8/19/2013
87HTOREAMER
118NOT LISTED
341REGISTERED
Detroit District Office (DET-DO)
8/19/2013
87HTOREAMER
118NOT LISTED
341REGISTERED
Detroit District Office (DET-DO)
6/29/2012
84HAWINSTRUMENT, STEREOTAXIC
118NOT LISTED
New Orleans District Office (NOL-DO)
9/9/2011
79GDFGUIDE, NEEDLE, SURGICAL
118NOT LISTED
New Orleans District Office (NOL-DO)
9/9/2011
79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY
118NOT LISTED
New Orleans District Office (NOL-DO)
9/9/2011
79HXHGUIDE
118NOT LISTED
New Orleans District Office (NOL-DO)
9/9/2011
79HXHGUIDE
118NOT LISTED
New Orleans District Office (NOL-DO)
9/9/2011
87HWCSCREW, FIXATION, BONE
118NOT LISTED
New Orleans District Office (NOL-DO)
8/23/2011
87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE
118NOT LISTED
New Orleans District Office (NOL-DO)
8/23/2011
87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE
118NOT LISTED
New Orleans District Office (NOL-DO)
8/23/2011
87HWCSCREW, FIXATION, BONE
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Fh Orthopedics's FDA import refusal history?

Fh Orthopedics (FEI: 3006356426) has 11 FDA import refusal record(s) in our database, spanning from 8/23/2011 to 8/19/2013.

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. Fh Orthopedics's FEI number is 3006356426.

What types of violations has Fh Orthopedics received?

Fh Orthopedics 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 Fh Orthopedics come from?

All FDA import refusal data for Fh Orthopedics 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.