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Zimmer Surgical SA

✅ Low Risk

FEI: 5634 • Plan-Les-Ouates, Geneva • SWITZERLAND

FEI

FEI Number

5634

📍

Location

Plan-Les-Ouates, Geneva

🇨🇭
🏢

Address

Chemin Du Pre-Fleuri 3, , Plan-Les-Ouates, Geneva, Switzerland

Low Risk

FDA Import Risk Assessment

23.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
8/30/2013
Latest Refusal
8/30/2013
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

3414×

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
8/30/2013
79HABSAW, POWERED, AND ACCESSORIES
341REGISTERED
Division of Southeast Imports (DSEI)
8/30/2013
79HABSAW, POWERED, AND ACCESSORIES
341REGISTERED
Division of Southeast Imports (DSEI)
8/30/2013
79MOQBATTERY, REPLACEMENT, RECHARGEABLE
341REGISTERED
Division of Southeast Imports (DSEI)
8/30/2013
79MOQBATTERY, REPLACEMENT, RECHARGEABLE
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Zimmer Surgical SA's FDA import refusal history?

Zimmer Surgical SA (FEI: 5634) has 4 FDA import refusal record(s) in our database, spanning from 8/30/2013 to 8/30/2013.

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. Zimmer Surgical SA's FEI number is 5634.

What types of violations has Zimmer Surgical SA received?

Zimmer Surgical SA 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 Zimmer Surgical SA come from?

All FDA import refusal data for Zimmer Surgical SA 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.