Z-0045-2017Class II

ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary...

Name: Z-0045-2017 ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary...
Creator: LDR Spine USA, Inc.
Published: 2016-08-29
License: https://open.fda.gov/license/

Ldr Spine USA / initiated 2016-08-29 / Terminated / root cause: design

FDA source

LDR Spine USA, Inc. began a recall of ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system... on 2016-08-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0045-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-29
Posted: 2016-10-05
Terminated: 2017-01-13
Recalling firm: Ldr Spine USA
Product: 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 code: LXH Orthopedic Manual Surgical Instrument
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
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 24 units
Distribution: US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
Product codes and lots: Lot # 2295101A, 2295101A-R, 2296101A-R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0045-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0045-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-05

Product code LXH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)