Synthes (USA) Products LLC: Medical Device Recall in 2015 - (Recall #: Z-0931-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 6, 2014

Date Posted: January 14, 2015

Recall Number: Z-0931-2015

Event ID: 69753

Reason for Recall:

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.

Status: Terminated

Product Quantity: 12

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

Voluntary or Mandated:

Voluntary: Firm initiated