Recall Z-1351-2021 ยท HSB Rod, Fixation, Intramedullary And Accessories
Nuvasive Specialized Orthopedics Inc
NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm, +0mm; Packaged End Cap 8.5/10.7mm, +5mm; Packaged End Cap 8.5/10.7mm, +10mm; Packaged End Cap 8.5/10.7mm, +15mm; Packaged End Cap 8.5/10.7mm, +20mm; Packaged End Cap 12.5mm, +0mm; Packaged End Cap 12.5mm, +5mm; Packaged End Cap 12.5mm, +10mm; Packaged End Cap 12.5mm, +15mm; Packaged
| 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 | 59 units |
| Distribution | Worldwide distribution, including U.S. Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141739 | RESIDUAL LIMB LENGTHENING SYSTEM Ellipse Technologies, Inc., Oct 7, 2014 |