FDA-Device2016-10-12Class II
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
LDR Spine USA, Inc.
Hazard
The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury
Sold states
US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
Affected count
24 units
Manufactured in
13785 Research Blvd Ste 200, N/A, Austin, TX, United States
Products
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0045-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief