Recall Z-2076-2014 ยท JDQ Cerclage, Fixation
PIONEER SURGICAL TECHNOLOGY, INC.
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.
| Date | Jul 17, 2014 (initiated Jun 11, 2014) |
| Status | Terminated |
| Reason | Lack of Sterility Assurance |
| Root cause | 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 | 5 |
| Distribution | US Nationwide Distribution in the states of TX and FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133785 | TRITIUM STERNAL CABLE PLATE SYSTEM Pioneer Surgical Technology, Inc., Jan 27, 2014 |