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U.S. Department of Health and Human Services

Class 2 Device Recall RTI Surgical Streamline OccipitoCervicoThoracic (OCT) Final Driver

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  Class 2 Device Recall RTI Surgical Streamline OccipitoCervicoThoracic (OCT) Final Driver see related information
Date Initiated by Firm March 18, 2016
Create Date October 11, 2018
Recall Status1 Terminated 3 on September 12, 2016
Recall Number Z-1393-2016
Recall Event ID 73659
510(K)Number K150254  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
Product RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
Code Information 26-FNLDRIVER, Lot Numbers: 177091, 177093, 183817, 207727, 223926, 227291, 229134, 230523, 232262, 233074, 234205
Recalling Firm/
Manufacturer		 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
375 River Park Cir
Marquette MI 49855-1781
For Additional Information Contact Dan Nelson
906-226-4489
Manufacturer Reason
for Recall		 Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use.
FDA Determined
Cause 2		 Process design
Action RTI Surgical Inc. initiated a voluntary recall of RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Final Driver, via written notices sent by e-mail and FedEx on 03/18/2016. Customers are requested to review all inventory, quarantine products listed in the recall, and to immediately return recalled products with the recall reply form, and the shipping labels and authorization numbers provided within 5 days of receiving notice. Replacement drivers are being sent to customers. Customers may contact Dan Nelson, Manager of Quality Systems, Phone: 906-226-4489, Fax: 906-226-4455, e-mail: dnelson@rtix.com.
Distribution Domestic: AL, CO, CT, FL, IN, ID, IL, MI, MS, MO, NC, NY, TX Foreign: None VA/DOD: None
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 = KWP and Original Applicant = Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
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