BIOMECANICA INDUSTRIA E COMERCIO DE PRODUTOS ORTOPEDICOS LTDA
⚠️ Moderate Risk
FEI: 3009685086 • Jau, Sao Paulo • BRAZIL
FEI Number
3009685086
Location
Jau, Sao Paulo
Country
BRAZILAddress
Rua Luiz Pengo, 145, , Jau, Sao Paulo, Brazil
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).
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).
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 |
|---|---|---|---|
| 9/17/2012 | 87HXYBRACE, DRILL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/17/2012 | 87MJTPROSTHESIS, SHOULDER, HUMERAL (BIPOLAR HEMI-SHOULDER) METAL/POLYMER, CEMENTED OR UNCEMENTED | Florida District Office (FLA-DO) | |
| 9/17/2012 | 87JECCOMPONENT, TRACTION, INVASIVE | Florida District Office (FLA-DO) | |
| 9/17/2012 | 87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL | Florida District Office (FLA-DO) | |
| 9/17/2012 | 87NQOPROSTHESIS, SPINOUS PROCESS SPACER/PLATE | Florida District Office (FLA-DO) | |
| 9/17/2012 | 87HRSPLATE, FIXATION, BONE | Florida District Office (FLA-DO) | |
| 9/17/2012 | 87JDSNAIL, FIXATION, BONE | Florida District Office (FLA-DO) | |
| 9/17/2012 | 87JDODEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT | Florida District Office (FLA-DO) | |
| 9/17/2012 | 87OBMCEMENT, BONE, VERTEBROPLASTY, PRE-FORMED, MODULAR | Florida District Office (FLA-DO) | |
| 9/17/2012 | 87NOVANCHOR, SUTURE, BONE FIXATION, METALLIC | Florida District Office (FLA-DO) | |
| 9/17/2012 | 87HWCSCREW, FIXATION, BONE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/17/2012 | 87LRNWIRE, SURGICAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/17/2012 | 87MUFSYSTEM, JOINT RESTORATION, ARTHROSCOPICALLY DIRECTED | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/17/2012 | 87LXIGUIDE, DRILL, LIGAMENT | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/17/2012 | 87HXCWRENCH | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/17/2012 | 87HTWBIT, DRILL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/17/2012 | 79NSZLUBRICANT, IMPLANT, INSERTION AID | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/17/2012 | 87OONFEMORAL HIP PROSTHESIS RESURFACING WITH RESECTION OF THE FEMORAL HEAD | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/17/2012 | 80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/17/2012 | 79KIKHOOK, BONE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/17/2012 | 87NKHORTHOSIS, PEDICLE SCREW SPINAL SYSTEM, SPONDYLOSIS AND FACET DEGENERATION | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/17/2012 | 87MZZPROSTHESIS, FEMORAL NAIL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/17/2012 | 87JDTCAP, BONE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/17/2012 | 87MBEBONE, BLOCK, FILLER, METAL, POROUS, UNCEMENTED | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is BIOMECANICA INDUSTRIA E COMERCIO DE PRODUTOS ORTOPEDICOS LTDA's FDA import refusal history?
BIOMECANICA INDUSTRIA E COMERCIO DE PRODUTOS ORTOPEDICOS LTDA (FEI: 3009685086) has 24 FDA import refusal record(s) in our database, spanning from 9/17/2012 to 9/17/2012.
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. BIOMECANICA INDUSTRIA E COMERCIO DE PRODUTOS ORTOPEDICOS LTDA's FEI number is 3009685086.
What types of violations has BIOMECANICA INDUSTRIA E COMERCIO DE PRODUTOS ORTOPEDICOS LTDA received?
BIOMECANICA INDUSTRIA E COMERCIO DE PRODUTOS ORTOPEDICOS LTDA 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 BIOMECANICA INDUSTRIA E COMERCIO DE PRODUTOS ORTOPEDICOS LTDA come from?
All FDA import refusal data for BIOMECANICA INDUSTRIA E COMERCIO DE PRODUTOS ORTOPEDICOS LTDA 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.