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U.S. Department of Health and Human Services

Class 2 Device Recall STREAMLINE CT CERVICOTHORACIC SYSTEM

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  Class 2 Device Recall STREAMLINE CT CERVICOTHORACIC SYSTEM see related information
Date Initiated by Firm September 10, 2012
Date Posted September 03, 2014
Recall Status1 Terminated 3 on September 30, 2014
Recall Number Z-2573-2014
Recall Event ID 69033
510(K)Number K112757  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
Product STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW
REF 26-SETSCREW
NON-STERILE, SINGLE USE, RX ONLY
Code Information Lot numbers: 104875, 104876, 104877, 104878, 104879, 104880, 104881 , 117030,117031 , 121947, 124260.
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		 Some set screw thread profiles were found not to be within specifications.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recall took place at the distributor/sales representative level. Communication was done through phone and email notifications on 9/10/2012. All affected set screws were to be traded out through a scheduled process. This was coordinated through Pioneer Surgical's customer service. Product was scrapped and no reconditioning took place. All affected set screws were swapped out.
Quantity in Commerce 11 sets
Distribution Distributed in the states of NC, NH, NY, CA, MI, 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 = KWP and Original Applicant = PIONEER SURGICAL TECHNOLOGY, INC.
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