Howmedica International S de RL
⚠️ Moderate Risk
FEI: 3002807172 • Limerick • IRELAND
FEI Number
3002807172
Location
Limerick
Country
IRELANDAddress
Raheen Business Park, , Limerick, , Ireland
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2020 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | Division of Southeast Imports (DSEI) | |
| 9/3/2020 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | Division of Southeast Imports (DSEI) | |
| 9/3/2020 | 87MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/ | Division of Southeast Imports (DSEI) | |
| 9/3/2020 | 87MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/ | Division of Southeast Imports (DSEI) | |
| 9/3/2020 | 87MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/ | Division of Southeast Imports (DSEI) | |
| 9/3/2020 | 87MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/ | Division of Southeast Imports (DSEI) | |
| 9/3/2020 | 87MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/ | Division of Southeast Imports (DSEI) | |
| 3/15/2017 | 87LODBONE CEMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/20/2013 | 87LODBONE CEMENT | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Howmedica International S de RL's FDA import refusal history?
Howmedica International S de RL (FEI: 3002807172) has 9 FDA import refusal record(s) in our database, spanning from 12/20/2013 to 9/3/2020.
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. Howmedica International S de RL's FEI number is 3002807172.
What types of violations has Howmedica International S de RL received?
Howmedica International S de RL 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 Howmedica International S de RL come from?
All FDA import refusal data for Howmedica International S de RL 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.