CORENTEC CO., LTD FDA Record
- Latest inspection VAI · Aug 29, 2024
- No warning letters matched by name
CORENTEC CO., LTD has 3 FDA recalls, 4 inspections, 33 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "CORENTEC CO., LTD" is on file.
- Latest recall
- Z-1934-2024 · Class II · Mar 29, 2024
- Latest inspection
- Aug 29, 2024 · VAI
- Latest 510(k)
- Apr 17, 2025
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 3 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 33 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 4 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
CORENTEC CO., LTD: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 2 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 1 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1934-2024 | Class II | LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description… | Mar 29, 2024 |
| Z-1935-2024 | Class II | LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product… | Mar 29, 2024 |
| Z-1454-2017 | Class II | Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343 | Feb 27, 2017 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 29, 2024 | Cheonan, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3009106092 |
| Oct 31, 2019 | Cheonan, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3009106092 |
| Apr 9, 2015 | Cheonan, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3009106092 |
| Jan 16, 2014 | Cheonan, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3009106092 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3009106092 | Cheonan, Korea (The Republic Of) | 4 | Aug 29, 2024 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K250889 | EXULT Knee Replacement System | Apr 17, 2025 |
| K242401 | EXULT Knee Replacement System | Sep 12, 2024 |
| K242046 | EXULT Knee Replacement System | Aug 1, 2024 |
| K223828 | BENCOX Delta Option Heads | Mar 16, 2023 |
| K223223 | BENCOX Mirabo Z Cup Cortinium | Feb 27, 2023 |
| K222278 | LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation | Aug 26, 2022 |
| K210614 | BENCOX Mirabo Z Cup Cortinium | May 24, 2022 |
| K220468 | BENCOX Mirabo Cup System | May 18, 2022 |
| K212034 | LOSPA TKR System | Dec 9, 2021 |
| K211866 | Bencox THR System | Jul 14, 2021 |
| K201851 | EXULT Femoral component trial - Left, EXULT Femoral component trial - Right | Jul 30, 2020 |
| K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | May 7, 2020 |
| K200267 | LOSPA® IS Spinal Fixation System | Mar 6, 2020 |
| K192507 | LOSPA II Knee System | Dec 11, 2019 |
| K182221 | Bencox Mirabo Cup Multi Hole | Apr 1, 2019 |
| K172806 | Bencox Mirabo Cup System | Oct 17, 2017 |
| K170243 | LOSPA IS TLIF & DLIF Cages | Mar 31, 2017 |
| K161641 | LOSPA IS ACP System | Jan 5, 2017 |
| K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Dec 5, 2016 |
| K160157 | LOSPA Modular Knee System | Dec 1, 2016 |
CORENTEC CO., LTD and the FDA: common questions
Has CORENTEC CO., LTD received an FDA warning letter?
No FDA warning letter addressed to the name "CORENTEC CO., LTD" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has CORENTEC CO., LTD received an FDA Form 483?
FDA has not published a Form 483 for "CORENTEC CO., LTD" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect CORENTEC CO., LTD?
The most recent FDA inspection on file ended Aug 29, 2024 at Cheonan, Korea (The Republic Of) and was classified VAI. FDA has 4 inspections of CORENTEC CO., LTD on file.
Has CORENTEC CO., LTD had an FDA recall?
Yes. CORENTEC CO., LTD has 3 FDA recalls on record. The most recent started Mar 29, 2024.
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