Devices

Device Recall Innovasis Excella II Standard

Model / Serial
E2S47525 Lot 1301 and E2S47535 Lot 1301
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
Product Description
Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
Manufacturer
Innovasis, Inc
1 Event
- Recall of Device Recall Innovasis Excella II Standard

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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