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.
FDA Recall Z-0045-2017 · Posted 2016-10-05
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Recalling FirmLDR Spine USA, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2016-08-29
Date Terminated2017-01-13
Product Quantity24 units
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
Firm Action
The firm, LDR, contacted affected consignees via phone and then sent a follow up email dated 9/8/16. The phone script and email described the product, problem and actions to be taken. The consignees were instructed to promptly return the instrument using the RMA#1180. The firm will perform a rework that prevents the binding to occur.
If you have any question, contact the Quality Engineering Manager by email: [email protected], phone: 512-344-3436 or Field Inventory Manager - US Supply Chain or phone: 512-344-3436.
Root Cause
Device Design
Distribution Pattern
US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant SystemLdr Spine USA · 2016-03-31K113027SYNGO AORTIC VALVEGUIDE SOFTWARESiemens Medical Solutions USA, Inc. · 2011-11-22K090507MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEMLdr Spine USA · 2009-06-25K082262LDR SPINE ROI INTERBODY FUSION SYSTEMLdr Spine USA · 2009-02-02
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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