LDR Spine USA, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0045-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 29, 2016

Date Posted: October 12, 2016

Recall Number: Z-0045-2017

Event ID: 75068

Reason for Recall:

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

Status: Terminated

Product Quantity: 24 units

Code Information:

Lot # 2295101A, 2295101A-R, 2296101A-R

Distribution Pattern:

US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.

Voluntary or Mandated:

Voluntary: Firm initiated