Recall Z-0644-2018
Innovasis, Inc · initiated January 8, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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:
Codes / lots: 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.
Reason for recall
Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
FDA-determined cause: Nonconforming Material/Component
Action taken
The distributors were notified of the recall on 1/8/2018 via email with an attached pdf. They are also being asked to confirm or deny the quantities showing in inventory via a Product Removal Form sent in the same email.
Details
- Recall number
- Z-0644-2018
- Initiated
- January 8, 2018
- Terminated
- February 27, 2018
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 1,010 parts
- Distribution
- United States
- Recalling firm
- Innovasis, Inc, Salt Lake City, UT