Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: Recalled by LDR Spine USA, Inc. Due to The ROI-A Anterior Delivery Device T-Handle, part number...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LDR Spine USA, Inc. directly.
Affected 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.
Quantity: 24 units
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed to 7 states: AR, FL, GA, KY, NC, OR, PA
About LDR Spine USA, Inc.
LDR Spine USA, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report