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.

Reason: 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.

Code information: All lots of part number 05.001.175, lot numbers: 28, 40, 41, 42, 53, 105, 107, 111, 112, 113, 115.

Distribution pattern: US Nationwide Distribution to Florida only