Recall Z-0644-2018 ยท NKB Thoracolumbosacral Pedicle Screw System
Innovasis, Inc
Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:
| Date | Jan 8, 2018 |
| Status | Terminated |
| Reason | Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage. |
| Root cause | Nonconforming Material/Component |
| Action | The distributors were notified of the recall on 1/8/2018 via email with an attached pdf. They are also being asked to confirm or deny the quantities showing in inventory via a Product Removal Form sent in the same email. |
| Quantity | 1,010 parts |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102248 | EXCELLA II SPINAL SYSTEM MODEL EC2-00 Innovasis, Inc., Oct 7, 2010 |