Field Orthopaedics
⚠️ Moderate Risk
FEI: 3015131017 • Spring Hill, Queensland • AUSTRALIA
FEI Number
3015131017
Location
Spring Hill, Queensland
Country
AUSTRALIAAddress
375 Wickham Tce, , Spring Hill, Queensland, Australia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/12/2021 | 87HWWCOUNTERSINK | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/12/2021 | 87HTYPIN, FIXATION, SMOOTH | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/12/2021 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/12/2021 | 79GAHSTYLET, SURGICAL, GENERAL & PLASTIC SURGERY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/12/2021 | 87HTJGAUGE, DEPTH | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/12/2021 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Field Orthopaedics's FDA import refusal history?
Field Orthopaedics (FEI: 3015131017) has 6 FDA import refusal record(s) in our database, spanning from 1/12/2021 to 1/12/2021.
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. Field Orthopaedics's FEI number is 3015131017.
What types of violations has Field Orthopaedics received?
Field Orthopaedics 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 Field Orthopaedics come from?
All FDA import refusal data for Field Orthopaedics 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.