FDA-Device2018-02-28Class II
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:
Innovasis, Inc
Hazard
Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
Sold states
United States
Affected count
1,010 parts
Manufactured in
614 E 3900 S, N/A, Salt Lake City, UT, United States
Products
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:
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0644-2018Don't want to check this manually?
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