Reported Oct 12, 2016 · Terminated
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument…
LDR Spine USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LDR Spine USA, Inc. · 13785 Research Blvd Ste 200 · Austin, TX · 78750-1895
Is this the product you have?
- ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument
- Model numberSI-ROIA-0023 Auxiliary instrument
- used in the ROI-A-ALIR cage systemSpinal intervertbral body fusion device
- Lot codes and dates
Lot # 2295101A2295101A-R2296101A-R
- Amount recalled
- 24 units
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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