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U.S. Department of Health and Human Services

Class 2 Device Recall Tritium Sternal Plate System

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  Class 2 Device Recall Tritium Sternal Plate System see related information
Date Initiated by Firm June 11, 2014
Date Posted July 17, 2014
Recall Status1 Terminated 3 on October 22, 2014
Recall Number Z-2076-2014
Recall Event ID 68619
510(K)Number K133785  
Product Classification Cerclage, fixation - Product Code JDQ
Product Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile.

The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.
Code Information Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018
Recalling Firm/
Manufacturer		 PIONEER SURGICAL TECHNOLOGY, INC.
375 River Park Cir
Marquette MI 49855-1781
For Additional Information Contact Dan Nelson
906-226-4812
Manufacturer Reason
for Recall		 Lack of Sterility Assurance
FDA Determined
Cause 2		 Employee error
Action On 6/11/14 and 6/12/14 the firm contacted their two consignees and surgeon via phone and explained that the product did not go through the sterilization process. The returns authorization number and shipping labels were discussed for the unused unit. On 6/18/14 and 6/20/14 an URGENT: MEDICAL DEVICE VOLUNTARY RECALL NOTIFICATION was sent to the customers as well as the one surgeon. The letter explained the sterility concerns and that the productis being recalled. Contact Dan Nelson, Manager of Quality, at 906-226-4489 if you have any questions or concerns.
Quantity in Commerce 5
Distribution US Nationwide Distribution in the states of TX 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 = JDQ and Original Applicant = PIONEER SURGICAL TECHNOLOGY, INC
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