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Z-2076-2014 Class II Terminated

Recalled by PIONEER SURGICAL TECHNOLOGY, INC. — Marquette, MI

FDA device recall Z-2076-2014 was initiated by PIONEER SURGICAL TECHNOLOGY, INC. on June 11, 2014 and is designated Class II. Reason for recall: Lack of Sterility Assurance The recall status is terminated (terminated October 22, 2014). Affected quantity: 5.

Recall Details

Product Type: Devices
Report Date: July 23, 2014
Initiation Date: June 11, 2014
Termination Date: October 22, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5

Product Description

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.

Reason for Recall

Lack of Sterility Assurance

Distribution Pattern

US Nationwide Distribution in the states of TX and FL

Code Information

Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018