Vista Improved Extended Retractor System
KOROS U.S.A., INC. · Model 7319-02 · UDI-DI 10840199543578
Description
Vista Improved Extended Retractor System Consists of the Following: 1 x 7319-11, 1 x 7319-12, 1 x 7319-13, 2 x 7319-20, 1 x 7319-21, 2 x 7319-30, 2 x 7319-31, 2 x 7319-32, 2 x 7319-33, 2 x 7319-34, 2 x 7319-35, 2 x 7319-36, 2 x 7319-37, 2 x 7319-38, 2 x 7319-39, 1 x 7319-40, 1 x 7319-41, 1 x 7319-42, 1 x 7319-43, 1 x 7319-44, 1 x 7319-45, 1 x 7319-46, 1 x 7319-47, 1 x 7319-48, 1 x 7319-50, 1 x 7319-51, 1 x 7319-52, 1 x 7319-53, 1 x 7319-54, 1 x 7319-55, 1 x 7319-56, 1 x 7319-57, 2 x 7319-60, 2 x 7319-61, 2 x 7319-62, 2 x 7319-63, 2 x 7319-64, 2 x 7319-65, 2 x 7319-66, 2 x 7319-67, 2 x 7319-70, 2 x 7319-71, 2 x 7319-72, 2 x 7319-73, 2 x 7319-74, 2 x 7319-75, 2 x 7319-76 & 2 x 7319-77
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. |
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