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Cadence™

Ascension Orthopedics, Inc. · Model 10209329 · UDI-DI 10381780239727

HSN Prescription

510(k) clearances

6,959

Adverse events (3 deaths)

Recalls

Facilities

Description

The Cadence™ Insert components are made out of highly cross-linked polyethylene UHMWPE, rigidly fixed to the Tibial Tray intra-operatively. In conjunction with the Talar Dome and Tibial Tray, the system is intended for both primary surgery and revision surgery applications which are designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. These components are available in a variety of sizes and design configurations.

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 been missing an inte
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 preventing pin placement thr
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 Tibial Insert, Fixed B

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Data 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.