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Zimmer Biomet CMF and Thoracic LLC

⚠️ Moderate Risk

FEI: 1032347 • Jacksonville, FL • UNITED STATES

FEI

FEI Number

1032347

📍

Location

Jacksonville, FL

🇺🇸
🏢

Address

1520 Tradeport Dr, , Jacksonville, FL, United States

Moderate Risk

FDA Import Risk Assessment

29.1
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
12/14/2009
Latest Refusal
9/22/2009
Earliest Refusal

Score Breakdown

Violation Severity
43.3×40%
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).

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
12/14/2009
79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
341REGISTERED
508NO 510(K)
Division of Southeast Imports (DSEI)
9/22/2009
87HWCSCREW, FIXATION, BONE
341REGISTERED
508NO 510(K)
Division of Southeast Imports (DSEI)
9/22/2009
79KCXEPILATOR, HIGH FREQUENCY, TWEEZER-TYPE
341REGISTERED
Division of Southeast Imports (DSEI)
9/22/2009
87HRSPLATE, FIXATION, BONE
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Zimmer Biomet CMF and Thoracic LLC's FDA import refusal history?

Zimmer Biomet CMF and Thoracic LLC (FEI: 1032347) has 4 FDA import refusal record(s) in our database, spanning from 9/22/2009 to 12/14/2009.

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 Biomet CMF and Thoracic LLC's FEI number is 1032347.

What types of violations has Zimmer Biomet CMF and Thoracic LLC received?

Zimmer Biomet CMF and Thoracic 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 Zimmer Biomet CMF and Thoracic LLC come from?

All FDA import refusal data for Zimmer Biomet CMF and Thoracic 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.