Home › Device types › HSN
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
FDA product code HSN · Class 2 · Orthopedic
4,536
Registered devices
7,185
Adverse events
47
Recalls
69
510(k) clearances
Devices with this code
INVISION — WRIGHT MEDICAL TECHNOLOGY, INC.APEX 3D Total Ankle Replacement System — Paragon 28, Inc.Cadence™ — Ascension Orthopedics, Inc.Vantage — Exactech, Inc.Incompass Total Ankle System — WRIGHT MEDICAL TECHNOLOGY, INC.Vantage — Exactech, Inc.INFINITY — WRIGHT MEDICAL TECHNOLOGY, INC.XT Revision Ankle Replacement System — Smith & Nephew, Inc.SALTO XT — TORNIERKinos Instrumentation — Restor3d, Inc.INFINITY — WRIGHT MEDICAL TECHNOLOGY, INC.Integra® XT — Ascension Orthopedics, Inc.Kinos Axiom — Restor3d, Inc.INBONE — WRIGHT MEDICAL TECHNOLOGY, INC.Kinos Axiom — Restor3d, Inc.APEX 3D Total Ankle Replacement System — Paragon 28, Inc.Kinos Instrumentation — Restor3d, Inc.INVISION — WRIGHT MEDICAL TECHNOLOGY, INC.Vantage — Exactech, Inc.Vantage — Exactech, Inc.Kinos Total Ankle Replacement — Restor3d, Inc.Kinos Axiom Instrumentation — Restor3d, Inc.INFINITY — WRIGHT MEDICAL TECHNOLOGY, INC.Kinos Axiom — Restor3d, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-06 | Wright Medical Technology, Inc. | Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have |
| 2023-11-21 | Exactech, Inc. | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2023-06-13 | Wright Medical Technology, Inc. | The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventi |
| 2022-09-30 | Wright Medical Technology, Inc. | The tibial tray lock detail is oversized (larger than specification). |
| 2022-09-30 | Wright Medical Technology, Inc. | The tibial tray lock detail is oversized (larger than specification). |
| 2022-06-02 | Wright Medical Technology, Inc. | The instrument is incorrectly color coded. |
| 2021-11-04 | Wright Medical Technology Inc | The package contents and package labeling do not match. |
| 2021-11-04 | Wright Medical Technology Inc | The package contents and package labeling do not match. |
| 2021-08-30 | Exactech, Inc. | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| 2020-08-10 | Exactech, Inc. | The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Ti |
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