Recall Z-2076-2014
Pioneer Surgical Technology, Inc. · initiated June 11, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018
Reason for recall
Lack of Sterility Assurance
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-2076-2014
- Initiated
- June 11, 2014
- Posted by FDA
- July 17, 2014
- Terminated
- October 22, 2014
- Product code
- JDQ – Cerclage, Fixation
- Quantity
- 5
- Distribution
- US Nationwide Distribution in the states of TX and FL
- Recalling firm
- Pioneer Surgical Technology, Inc., Marquette, MI