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LDR Spine USA, Inc. recalls ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrume
Recalled October 12, 2016 · FDA recall Z-0045-2017 · LDR Spine USA
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 · FDA Class II
Units
24 units
Sold at
US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
Description
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
Product
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.
Manufacturer(s)
LDR Spine USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →