CORIN MEDICAL, LTD.

⚠️ Moderate Risk

FEI: 3002806725 • Cirencester, Gloucestershire • UNITED KINGDOM

FEI

FEI Number

3002806725

📍

Location

Cirencester, Gloucestershire

🇬🇧

Country

UNITED KINGDOM

🏢

Address

Unit 1-57-8, Corinium Centre, Cirencester, Gloucestershire, United Kingdom

Moderate Risk

FDA Import Risk Assessment

44.0

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

10/18/2010

Latest Refusal

6/4/2008

Earliest Refusal

Score Breakdown

Violation Severity

50.5×40%

Refusal Volume

49.7×30%

Recency

0.0×20%

Frequency

88.5×10%

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

Violation Summary

50821×

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.

34120×

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
10/18/2010	87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL	508NO 510(K)	Division of Southeast Imports (DSEI)
6/4/2008	87NRAPROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87NRAPROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87NRAPROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87NRAPROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87NRAPROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87NRAPROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87NRAPROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/4/2008	87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is CORIN MEDICAL, LTD.'s FDA import refusal history?

CORIN MEDICAL, LTD. (FEI: 3002806725) has 21 FDA import refusal record(s) in our database, spanning from 6/4/2008 to 10/18/2010.

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. CORIN MEDICAL, LTD.'s FEI number is 3002806725.

What types of violations has CORIN MEDICAL, LTD. received?

CORIN MEDICAL, 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 CORIN MEDICAL, LTD. come from?

All FDA import refusal data for CORIN MEDICAL, 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.