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U.S. Department of Health and Human Services

Class 2 Device Recall ROIA Anterior Delivery Device

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  Class 2 Device Recall ROIA Anterior Delivery Device see related information
Date Initiated by Firm August 29, 2016
Date Posted October 05, 2016
Recall Status1 Terminated 3 on January 13, 2017
Recall Number Z-0045-2017
Recall Event ID 75068
510(K)Number K082262  K090507  K113027  K153495  
Product Classification Orthopedic manual surgical instrument - Product Code LXH
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.
Code Information Lot # 2295101A, 2295101A-R, 2296101A-R
Recalling Firm/
Manufacturer		 LDR Spine USA, Inc.
13785 Research Blvd Ste 200
Austin TX 78750-1895
For Additional Information Contact Mea Amor
512-344-3429
Manufacturer 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
FDA Determined
Cause 2		 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 in Commerce 24 units
Distribution US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LXH and Original Applicant = LDR SPINE USA
510(K)s with Product Code = LXH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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