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Retractor
FDA product code GAD · Class 1 · General, Plastic Surgery
35,083
Registered devices
1,646
Adverse events
44
Recalls
100
510(k) clearances
Devices with this code
Symmetry Bookwalter® — ASPEN SURGICAL PRODUCTS, INC.RZ Medizintechnik GmbH — RZ-Medizintechnik GmbHGen2 — SURGIX MEDICAL LLCGENERIC Surgical Instruments — CTL Medical CorporationSIGMA — ALPHATEC SPINE, INC.ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONCooley Atrial Valve Retractor — KOROS U.S.A., INC.Mayo-Balfour Swivel Retractor — KOROS U.S.A., INC.Integra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONOtto Leibinger — AMERICAN EAGLE INSTRUMENTS, INC.MicroGrip — FLEXBAR MACHINE CORPORATIONgSource — GSOURCE LLCgSource — GSOURCE LLCPLIF — DEPUY SPINE, LLCBR Surgical, LLC — BR Surgical, LLCSklar — SKLAR CORPORATIONGENERIC Surgical Instruments — CTL Medical CorporationSeaSpine Spacer System - Hollywood — Seaspine Orthopedics CorporationNovo Surgical Inc. — NOVO SURGICAL, INC.Mentor Radiolucent Serrated Multi Hook — KOROS U.S.A., INC.SOAR Retractor System — SPINEOLOGY INC.PEAK MEDICAL — Peak Medical Distribution Inc.American Medicals — American Medicals
Recent 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 |
| 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 t |
| 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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