Medical device recalls Moderate risk

Ceterix Orthopedics, Inc. recalls Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic access…

Recall date
May 16, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2945-2018
FDA classification
Class II
Brand / firm
Ceterix Orthopedics, Inc.
Sold / distributed
United States distribution.

Why it was recalled

Possible nonconforming blades may result in a higher than specified cut force required to cut the suture.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.

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