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:
Reported: February 28, 2018 Initiated: January 8, 2018 #Z-0644-2018
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:
Reason for Recall
Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
Details
- Recalling Firm
- Innovasis, Inc
- Units Affected
- 1,010 parts
- Distribution
- United States
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
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:. Recalled by Innovasis, Inc. Units affected: 1,010 parts.
Why was this product recalled? ▼
Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2018. Severity: Moderate. Recall number: Z-0644-2018.
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