Recall Z-0644-2018— Innovasis, Inc
Class II · Terminated
Class II FDA medical device recall by Innovasis, Inc, initiated 2018-01-08, terminated 2018-02-27. It names one FDA 510(k) clearance: K102248. Product: 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: Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage..
- Recalling firm
- Innovasis, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-08
- Terminated
- 2018-02-27
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.