Medical device recalls Moderate risk

Ceterix Orthopedics, Inc. recalls NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic s…

Recall date
October 13, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0250-2016
FDA classification
Class II
Brand / firm
Ceterix Orthopedics, Inc.
Sold / distributed
Nationwide Distribution

Why it was recalled

The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.

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

What was recalled

NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.

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