Synthes, Inc. recalls Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instru…

Recall date

December 15, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0973-2015

FDA classification

Class II

Brand / firm

Synthes, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) and internationally to Canada.

Why it was recalled

Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material. Surgical delay may occur. Spring particles could transfer from the instrument to the patient, and may lead to an adverse tissue reaction and/or infection.

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

What was recalled

Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System.