STRYKER IRELAND OSTEONICS
⚠️ Moderate Risk
FEI: 3002459190 • County Cork, Cork Munster • IRELAND
FEI Number
3002459190
Location
County Cork, Cork Munster
Country
IRELANDAddress
Tullagreen Building, IDA Business & Technology Park, Carrigtwohill Industrial Estate, Carrigtwohill, County Cork, Cork Munster, 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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2020 | 87JDIPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED | Division of Southeast Imports (DSEI) | |
| 9/3/2020 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | Division of Southeast Imports (DSEI) | |
| 4/6/2020 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/6/2020 | 87JDIPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/6/2020 | 87LZOPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/6/2020 | 87JDIPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/6/2020 | 87JDIPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/6/2020 | 87LZOPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/6/2020 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/6/2020 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/6/2020 | 87JDQCERCLAGE, FIXATION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/6/2020 | 87JDQCERCLAGE, FIXATION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/6/2020 | 87JDQCERCLAGE, FIXATION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/9/2013 | 87HWCSCREW, FIXATION, BONE | 508NO 510(K) | Detroit District Office (DET-DO) |
| 5/9/2013 | 87HWCSCREW, FIXATION, BONE | 508NO 510(K) | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is STRYKER IRELAND OSTEONICS's FDA import refusal history?
STRYKER IRELAND OSTEONICS (FEI: 3002459190) has 15 FDA import refusal record(s) in our database, spanning from 5/9/2013 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. STRYKER IRELAND OSTEONICS's FEI number is 3002459190.
What types of violations has STRYKER IRELAND OSTEONICS received?
STRYKER IRELAND OSTEONICS has been cited for 3 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 STRYKER IRELAND OSTEONICS come from?
All FDA import refusal data for STRYKER IRELAND OSTEONICS 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.