Zhejiang Biomet Medical Products Co. Ltd.
⚠️ Moderate Risk
FEI: 3006801265 • Jinhua, Zhejiang • CHINA
FEI Number
3006801265
Location
Jinhua, Zhejiang
Country
CHINAAddress
980 Shenli Rd, , Jinhua, Zhejiang, China
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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 |
|---|---|---|---|
| 11/21/2017 | 87HWTTEMPLATE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/21/2017 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/21/2017 | 87HTOREAMER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/21/2017 | 87HWAIMPACTOR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/21/2017 | 87HWTTEMPLATE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/21/2017 | 79HTRRASP | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/8/2016 | 87HWTTEMPLATE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/26/2016 | 87HTOREAMER | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 10/26/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 10/26/2016 | 87HWAIMPACTOR | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 10/26/2016 | 87HWTTEMPLATE | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 10/25/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 10/25/2016 | 87HTOREAMER | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 10/25/2016 | 79HTRRASP | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 10/25/2016 | 87HWTTEMPLATE | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 10/25/2016 | 87HWPPUNCH, FEMORAL NECK | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 10/25/2016 | 87HWTTEMPLATE | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 10/25/2016 | 79FZYHAMMER, SURGICAL | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 10/24/2016 | 79HTRRASP | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/24/2016 | 87HWTTEMPLATE | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/24/2016 | 87HWPPUNCH, FEMORAL NECK | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/24/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 9/29/2016 | 87HWTTEMPLATE | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 9/29/2016 | 79FZOCHISEL, SURGICAL, MANUAL | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 9/29/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 9/29/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 9/29/2016 | 87HWTTEMPLATE | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 9/29/2016 | 87HTOREAMER | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 9/29/2016 | 87HWAIMPACTOR | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Zhejiang Biomet Medical Products Co. Ltd.'s FDA import refusal history?
Zhejiang Biomet Medical Products Co. Ltd. (FEI: 3006801265) has 29 FDA import refusal record(s) in our database, spanning from 9/29/2016 to 11/21/2017.
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. Zhejiang Biomet Medical Products Co. Ltd.'s FEI number is 3006801265.
What types of violations has Zhejiang Biomet Medical Products Co. Ltd. received?
Zhejiang Biomet Medical Products Co. 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 Zhejiang Biomet Medical Products Co. Ltd. come from?
All FDA import refusal data for Zhejiang Biomet Medical Products Co. 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.