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Mentor Cervical/Lumbar Extended Plus Retractor Set
KOROS U.S.A., INC. · Model 7318-04 · UDI-DI 10840199543554
GAD
Prescription
10
510(k) clearances
1,660
Adverse events (4 deaths)
44
Recalls
660
Facilities
Description
Mentor Cervical/Lumbar Extended Plus Retractor Set Consists of the Following: 1 x 7318-10, 1 x 7318-12, 1 x 7318-82, 2 x 7318-16, 1 x 7318-18, 2 x 7318-21, 2 x 7318-22, 2 x 7318-23, 2 x 7318-24, 2 x 7318-25, 2 x 7318-27, 2 x 7318-28, 2 x 7318-31, 2 x 7318-32, 2 x 7318-33, 2 x 7318-34, 2 x 7318-35, 2 x 7318-41, 2 x 7318-42, 2 x 7318-43, 2 x 7318-44, 3 x 7318-45,1 x 7318-51, 1 x 7318-52, 1 x 7318-53, 1 x 7318-54, 1 x 7318-55, 1 x 7318-56, 1 x 7318-61, 1 x 7318-62, 1 x 7318-63, 1 x 7318-64,, 1 x 7318-65, 1 x 7318-66 & 1 x 7318-20
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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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.