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U.S. Department of Health and Human Services

Class 2 Device Recall Streamline

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  Class 2 Device Recall Streamline see related information
Date Initiated by Firm June 14, 2013
Date Posted September 09, 2014
Recall Status1 Terminated 3 on September 30, 2014
Recall Number Z-2616-2014
Recall Event ID 69036
510(K)Number K130286  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product Streamline MIS Spinal Fixation System Fixed Rod Holder
NON STERILE, Rx only
The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
Code Information Lot number: 148062, 148440
Recalling Firm/
Manufacturer		 PIONEER SURGICAL TECHNOLOGY, INC.
375 River Park Cir
Marquette MI 49855-1781
For Additional Information Contact
906-226-4812
Manufacturer Reason
for Recall		 The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
FDA Determined
Cause 2		 Device Design
Action Pioneer Surgical sent a Product Field Action letter on July 7, 2013, to all affected customers. The letter described the affected product and issue, and provided instructions for return of the recalled product. All 9 affected instruments were returned to Pioneer Surgical, reconditioned and sent back to the field. Customers with questions were instructed to call 906-226-4489. For questions regarding this recall call 906-226-4812.
Quantity in Commerce 9
Distribution Nationwide Distribution including TX, CA, IL, and FL.
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 = NKB and Original Applicant = PIONEER SURGICAL TECHNOLOGY, INC
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