FDA Medical Device Recalls (openFDA)
LDR Spine USA, Inc.: 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.
- Recall number
- Z-0045-2017
- Recalling firm
- LDR Spine USA, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2016-08-29
- Posted
- 2016-10-05
- Terminated
- 2017-01-13
- Reason
- 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
- 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: ron.musselman@zimmerbiomet.com, phone: 512-344-3436 or Field Inventory Manager - US Supply Chain or phone: 512-344-3436.
- Quantity
- 24 units
- Distribution
- US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
- Lot, serial or model codes
- Lot # 2295101A, 2295101A-R, 2296101A-R
- 510(k) numbers
- ["K082262","K090507","K113027","K153495"]
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3004903783
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28