Medical device recalls Moderate risk

Toby Orthopaedics, Inc. recalls PANTERA Proximal Humerus Fracture Plate System

Recall date
June 5, 2013
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0599-2020
FDA classification
Class II
Brand / firm
Toby Orthopaedics, Inc.
Sold / distributed
Arkansas, Florida, Puerto Rico, Spain, Panama, Australia, UK

Why it was recalled

Potential suture clip breaking during a humerus fixation surgery.

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

What was recalled

PANTERA Proximal Humerus Fracture Plate System

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