Implants International Ltd.
✅ Low Risk
FEI: 1000547811 • Thornaby-On-Tees, North Riding of Yorkshire • UNITED KINGDOM
FEI Number
1000547811
Location
Thornaby-On-Tees, North Riding of Yorkshire
Country
UNITED KINGDOMAddress
71 Jay Avenue, , Thornaby-On-Tees, North Riding of Yorkshire, United Kingdom
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
Statistics
Score Breakdown
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
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).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/15/2019 | 87HWCSCREW, FIXATION, BONE | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 5/24/2012 | 87HXZCUTTER, WIRE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 5/24/2012 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 5/24/2012 | 87JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Implants International Ltd.'s FDA import refusal history?
Implants International Ltd. (FEI: 1000547811) has 4 FDA import refusal record(s) in our database, spanning from 5/24/2012 to 2/15/2019.
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. Implants International Ltd.'s FEI number is 1000547811.
What types of violations has Implants International Ltd. received?
Implants International Ltd. 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 Implants International Ltd. come from?
All FDA import refusal data for Implants International 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.