FDAFDA · Food and drugs·Recall number Z-0045-2017
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.
Published October 12, 2016 · Recall initiated: August 29, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- LDR Spine USA, Inc.
- Distributor
- US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
- Lot
- Lot # 2295101A, 2295101A-R, 2296101A-R
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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