Home › KOROS U.S.A., INC. › Extra Long/Deep Instrument Set
Extra Long/Deep Instrument Set
KOROS U.S.A., INC. · Model 9950-00 · UDI-DI 10840199544865
GAD
Prescription
10
510(k) clearances
1,660
Adverse events (4 deaths)
44
Recalls
660
Facilities
Description
Extra Long/Deep Instrument Set Consists of the Following: 1 x 9952-10, 1 x 9952-20, 1 x 9952-30, 1 x 9952-40, 1 x 9954-20, 1 x 9954-10, 2 x 9956-10, 2 x 9956-20, 2 x 9958-10, 3 x 9958-20, 1 x 9958-30, 1 x 9958-40, 1 x 9958-50, 2 x 9960-10, 2 x 9960-20, 2 x 9960-30, 2 x 9960-40, 2 x 9960-50, 2 x 9962-10, 2 x 9962-20, 1 x 9964-10, 2 x 9964-20, 2 x 9964-30, 2 x 9964-40, 1 x 9966-10 & 1 x 9968-50
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-05 | Integra LifeSciences Corp. (NeuroSciences) | The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 |
| 2025-04-09 | MEDLINE INDUSTRIES, LP - Northfield | Three is the potential for the retractors to puncture through the sterile packaging. |
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-05-17 | SEASPINE ORTHOPEDICS CORPORATION | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure |
| 2024-05-17 | SEASPINE ORTHOPEDICS CORPORATION | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2023-12-21 | Medagent Inc | Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which |
| 2023-05-25 | TELEFLEX LLC | There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). |
| 2023-05-25 | TELEFLEX LLC | There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). |
| 2022-12-08 | Medtronic Navigation, Inc. | Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.