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Arthroscope
FDA product code HRX · Class 2 · Orthopedic
5,844
Registered devices
25,912
Adverse events
126
Recalls
684
510(k) clearances
Devices with this code
ARTHROPUMP — Karl Storz GmbH & Co. KGIdeal Eyes — STRYKER CORPORATIONSurgical Direct — Surgical Direct, Inc.Sustainable Technologies — ProvisionArthrex — ProvisionMicroAire® — Microaire Surgical Instruments LLC1.2mm InnerVue II Scope Kit — BIOVISION TECHNOLOGIES, LLCARTHROFORCE / Take-Apart — Karl Storz GmbH & Co. KGArthroscopy sheath — SOPRO-COMEG GmbHArthroscope — SOPRO-COMEG GmbHISOTAC — Smith & Nephew, Inc.Zavation — Zavation LLCFMS — Medos International SàrlNA — STERILMED, INC.KyphPak® First Fracture Tray — MEDTRONIC SOFAMOR DANEK, INC.Medline — MEDLINE INDUSTRIES, INC.NA — Smith & Nephew, Inc.NA — Smith & Nephew, Inc.MEDINAUT Kyphoplasty System — IMEDICOM CO., LTD.EBERLE — Eberle GmbH & Co. KGOlympus — OLYMPUS Winter & Ibe GmbHArthrex® — ARTHREX, INC.Obturator — SOPRO-COMEG GmbHMedline ReNewal — MEDLINE INDUSTRIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-11 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been |
| 2024-10-11 | Karl Storz Endoscopy | Due to holes detected in the inner barrier system that may compromise the sterility of the affected products. |
| 2024-05-24 | WOM World Of Medicine AG | Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee |
| 2021-05-17 | ADRIA SRL | The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. |
| 2021-05-17 | ADRIA SRL | The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. |
| 2021-05-17 | ADRIA SRL | The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. |
| 2021-01-19 | ReNovo, Inc. | Non-sterile product was shipped to customers labelled as sterile. |
| 2020-06-24 | Smith & Nephew, Inc. | The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of the |
| 2020-04-24 | Medtronic Sofamor Danek USA Inc | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implanta |
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