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.
FDA Recall Z-2076-2014 · Posted 2014-07-17
Recalling FirmPIONEER SURGICAL TECHNOLOGY, INC.
Recall StatusTerminated
Product CodeJDQ
Date Initiated2014-06-11
Date Terminated2014-10-22
Product Quantity5
Reason for Recall
Lack of Sterility Assurance
Firm 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.
Root Cause
Employee error
Distribution Pattern
US Nationwide Distribution in the states of TX and FL
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.