Z-0644-2018 Class II Terminated
FDA device recall Z-0644-2018 was initiated by Innovasis, Inc on January 8, 2018 and is designated Class II. Reason for recall: Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage. The recall status is terminated (terminated February 27, 2018). Affected quantity: 1,010 parts.
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2018
- Initiation Date
- January 8, 2018
- Termination Date
- February 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,010 parts
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.
Distribution Pattern
United States
Code Information
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.