Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Excella II Polyaxial Pedicle Screw used as a pedicle screw Recalled by Innovasis, Inc Due to Nine lots of 8.5 mm Polyaxial Pedicle Screws...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Innovasis, Inc directly.
Affected 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:
Quantity: 1,010 parts
Why Was This Recalled?
Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
Where Was This Sold?
United States
About Innovasis, Inc
Innovasis, Inc has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report