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.

Recall Insight

This FDA Devices action (record #Z-0931-2015) was formally reported on January 14, 2015, with the manufacturer initiating the action on November 6, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Synthes (USA) Products LLC is listed as the recalling firm, operating out of West Chester, PA. Federal records indicate 12 units are affected.

The documented reason for this recall is: 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,… Distribution data in the federal record shows the product reached: US Nationwide Distribution to Florida only. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.