Recall Z-0045-2017— LDR Spine USA, Inc.
Class II · Terminated
Class II FDA medical device recall by LDR Spine USA, Inc., initiated 2016-08-29, terminated 2017-01-13. It names 4 FDA 510(k) clearances: K153495, K113027, K090507 and 1 more. 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.. 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.
- Recalling firm
- LDR Spine USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-29
- Terminated
- 2017-01-13
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
4 on FDA's record- K153495 — Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
- K113027 — SYNGO AORTIC VALVEGUIDE SOFTWARE
- K090507 — MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM
- K082262 — LDR SPINE ROI INTERBODY FUSION SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.