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Centerpulse Orthopedics Ltd

⚠️ Moderate Risk

FEI: 3003887902 • Winterthur, Zurich • SWITZERLAND

FEI

FEI Number

3003887902

📍

Location

Winterthur, Zurich

🇨🇭
🏢

Address

Spedition Und Wareneingang 541, , Winterthur, Zurich, Switzerland

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

1
Total Refusals
1
Unique Violations
1/31/2003
Latest Refusal
1/31/2003
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

23801×

NO PMA/PDP

The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).

Refusal History

DateProductViolationsDivision
1/31/2003
86HNPINTRODUCER, SPHERE
2380NO PMA/PDP
New York District Office (NYK-DO)

Frequently Asked Questions

What is Centerpulse Orthopedics Ltd's FDA import refusal history?

Centerpulse Orthopedics Ltd (FEI: 3003887902) has 1 FDA import refusal record(s) in our database, spanning from 1/31/2003 to 1/31/2003.

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. Centerpulse Orthopedics Ltd's FEI number is 3003887902.

What types of violations has Centerpulse Orthopedics Ltd received?

Centerpulse Orthopedics Ltd has been cited for 1 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 Centerpulse Orthopedics Ltd come from?

All FDA import refusal data for Centerpulse Orthopedics Ltd 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.