PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 14, 2015 Initiated: November 6, 2014 #Z-0931-2015

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.

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.

Details

Units Affected
12
Distribution
US Nationwide Distribution to Florida only
Location
West Chester, PA

Frequently Asked Questions

What product 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.. Recalled by Synthes (USA) Products LLC. Units affected: 12.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 14, 2015. Severity: Moderate. Recall number: Z-0931-2015.

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