Devices

Device Recall Polyaxial Pedicle Screw

Model / Serial
Catalog/Part No.: E2S8530, E2S8535, E2S8540, E2S8545, E2S8550, E2S8555, E2S8560 with Lot Number: 1101 and Catalog/Part No.: E28540, E28545 with Lot Number: 1201. Each of these parts is engraved with part number and lot number.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
United States
Product 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:
Manufacturer
Innovasis, Inc
1 Event
- Recall of Device Recall Polyaxial Pedicle Screw

Manufacturer

Innovasis, Inc

Manufacturer Address
Innovasis, Inc, 614 E 3900 S, Salt Lake City UT 84107-1902
Manufacturer Parent Company (2017)
Innovasis, Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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