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Bonecare Implants

⚠️ Moderate Risk

FEI: 3005150521 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

3005150521

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN
🏢

Address

U.K. Road, Saga Chowk, , Sialkot, Punjab, Pakistan

Moderate Risk

FDA Import Risk Assessment

38.5
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
11/1/2007
Latest Refusal
6/28/2005
Earliest Refusal

Score Breakdown

Violation Severity
72.5×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
17.1×10%
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

5083×

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.

4801×

STAINSTEEL

The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.

Refusal History

DateProductViolationsDivision
11/1/2007
87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT
480STAINSTEEL
New Orleans District Office (NOL-DO)
12/1/2005
87HRSPLATE, FIXATION, BONE
508NO 510(K)
New Orleans District Office (NOL-DO)
6/28/2005
87HWCSCREW, FIXATION, BONE
508NO 510(K)
New Orleans District Office (NOL-DO)
6/28/2005
87KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Bonecare Implants's FDA import refusal history?

Bonecare Implants (FEI: 3005150521) has 4 FDA import refusal record(s) in our database, spanning from 6/28/2005 to 11/1/2007.

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. Bonecare Implants's FEI number is 3005150521.

What types of violations has Bonecare Implants received?

Bonecare Implants 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 Bonecare Implants come from?

All FDA import refusal data for Bonecare Implants 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.