Recall Z-0291-2018 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Orthofix Srl
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
| Date | Jul 5, 2017 |
| Status | Terminated |
| Reason | The power drill torque limiter may break during use in surgery application. |
| Root cause | Process change control |
| Action | 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 customerservice@orthofix.it. Hospitals were i |
| Quantity | 416 units |
| Distribution | Worldwide Distribution -- US, including the states of CA, FL, & PA; and, the countries of Australia, Germany, Finland, France, Italy, Lithuania, Netherlands, Singapore, South Africa, Sweden, Switzerland, & United Kingdom. |
| FDA record | Open on fda.gov |