Synthes (USA) Products LLC recalls Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general tr…

Recall date

November 6, 2014

Source

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

Recall number

Z-0931-2015

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

US Nationwide Distribution to Florida only

Why it was recalled

The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue, peripheral nerve, and /or vascular damage. Injuries may need surgical or medical intervention. Surgical delay and postoperative local infection are also potential risks.

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

What was recalled

Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and hard tissue.