Recall Z-1350-2021 ยท HSB Rod, Fixation, Intramedullary And Accessories
Nuvasive Specialized Orthopedics Inc
NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 195 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter
| Date | Apr 5, 2021 (initiated Feb 12, 2021) |
| Status | Open, Classified |
| Reason | Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old. |
| Root cause | Device Design |
| Action | On 02/11/2021, the firm started emailing an "URGENT FIELD SAFETY NOTICE" Notification to customers informing them that due to not having the full complement of biological assessments, the devices are not indicated for use in individuals under the age of 18 years old. Customers are informed to: -An Recalling Firm representative will be contacting your office or you to help with any questions or concerns. -Review, complete, sign and return the attached Consignee Confirmation Form accompanying this notification in accordance with the directions on the form. -If a patient has been previously impl |
| Quantity | 229 units |
| Distribution | Worldwide distribution, including U.S. Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113695 | ELLIPSE PRECICE TRAUMA NAIL SYSTEM Ellipse Technologies, Inc., Mar 28, 2012 |