Stryker Trauma GmbH
⚠️ Moderate Risk
FEI: 3002807231 • Schonkirchen, Schleswig-Holstein • GERMANY
FEI
FEI Number
3002807231
📍
Location
Schonkirchen, Schleswig-Holstein
🇩🇪
Country
GERMANY🏢
Address
Prof.-Kuntscher-Str. 1-5, , Schonkirchen, Schleswig-Holstein, Germany
Moderate Risk
FDA Import Risk Assessment
42.4
LowModerateHighCritical
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
66
Total Refusals
2
Unique Violations
12/9/2020
Latest Refusal
12/8/2020
Earliest Refusal
Score Breakdown
Violation Severity
30.3×40%
Refusal Volume
67.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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
© ImportRefusal.com Original Analysis
Violation Summary
34165×
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).
1181×
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Stryker Trauma GmbH's FDA import refusal history?
Stryker Trauma GmbH (FEI: 3002807231) has 66 FDA import refusal record(s) in our database, spanning from 12/8/2020 to 12/9/2020.
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 Trauma GmbH's FEI number is 3002807231.
What types of violations has Stryker Trauma GmbH received?
Stryker Trauma GmbH 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 Stryker Trauma GmbH come from?
All FDA import refusal data for Stryker Trauma GmbH 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.