FDA Recall
Terminated
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:
Recall: Z-0644-2018
·
Initiated January 8, 2018
Recall
- Recall Number
- Z-0644-2018
- Event Number
- 78946
- Firm
- Innovasis, Inc
- FEI Number
- 3004719693
- Product Code
- NKB
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- January 8, 2018
- Terminated
- February 27, 2018
- Address
- 614 E 3900 S, Salt Lake City, UT, 84107-1902
Description
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:
Reason
Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
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.
Distribution
United States
Quantity
1,010 parts