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Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

FDA product code HSN · Class 2 · Orthopedic

4,529
Registered devices
6,959
Adverse events
47
Recalls
68
510(k) clearances

Devices with this code

Hintermann Series H2 — Dt Medtech, LLCAPEX 3D Total Ankle Replacement System — Paragon 28, Inc.APEX 3D Total Ankle Replacement System — Paragon 28, Inc.INVISION — WRIGHT MEDICAL TECHNOLOGY, INC.APEX 3D Total Ankle Replacement System — Paragon 28, Inc.Incompass Total Ankle System — WRIGHT MEDICAL TECHNOLOGY, INC.INFINITY — WRIGHT MEDICAL TECHNOLOGY, INC.APEX 3D Total Ankle Replacement System — Paragon 28, Inc.Cadence™ — Ascension Orthopedics, Inc.Trabecular Metal® — Zimmer, Inc.Salto Talaris® — Ascension Orthopedics, Inc.Kinos Total Ankle Replacement — Restor3d, Inc.APEX 3D Total Ankle Replacement System — Paragon 28, Inc.Cadence™ — Ascension Orthopedics, Inc.INBONE™ EVERLAST™ — WRIGHT MEDICAL TECHNOLOGY, INC.Cadence Total Ankle System — Smith & Nephew, Inc.APEX 3D Total Ankle Replacement System — Paragon 28, Inc.Trabecular Metal® — Zimmer, Inc.Kinos Axiom Instrumentation — Restor3d, Inc.APEX 3D Total Ankle Replacement System — Paragon 28, Inc.Hintermann Series H2 — Dt Medtech, LLCVantage — Exactech, Inc.APEX 3D Total Ankle Replacement System — Paragon 28, Inc.Cadence Total Ankle System — Smith & Nephew, Inc.

Recent recalls

DateFirmReason
2024-03-06Wright 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
2023-11-21Exactech, Inc.Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
2023-06-13Wright 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
2022-09-30Wright Medical Technology, Inc.The tibial tray lock detail is oversized (larger than specification).
2022-09-30Wright Medical Technology, Inc.The tibial tray lock detail is oversized (larger than specification).
2022-06-02Wright Medical Technology, Inc.The instrument is incorrectly color coded.
2021-11-04Wright Medical Technology IncThe package contents and package labeling do not match.
2021-11-04Wright Medical Technology IncThe package contents and package labeling do not match.
2021-08-30Exactech, Inc.Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
2020-08-10Exactech, 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.