Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.

The power drill torque limiter may break during use in surgery application.

Consignees were sent an Urgent Medical Device Recall Notification, dated June 28, 2017, informing them of the device correction. The letter instructed distributors to immediately identify affected product in warehouses, quarantine affected product, and communicate the amount on hand to Orthofix SRL for replacement. Any customers are to be forwarded the recall notice provided to the distributor. Distributors are asked to complete the Reply Form with the appropriate information and to return it to Orthofix by fax at +39-045-6719380 or by e-mail to [email protected]. Hospitals were instructed to identify affected product on-site, quarantine affected units, and communicate the quantity of affected product on-hand to their local distributor or to Orthofix. Affected product will be replaced by Orthofix.