Recall Z-2076-2014— PIONEER SURGICAL TECHNOLOGY, INC.

Name: FDA recall Z-2076-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-11

Class II · Terminated

Class II FDA medical device recall by PIONEER SURGICAL TECHNOLOGY, INC., initiated 2014-06-11, terminated 2014-10-22. It names one FDA 510(k) clearance: K133785. 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.. Reason: Lack of Sterility Assurance.

Recalling firm: PIONEER SURGICAL TECHNOLOGY, INC.
Classification: Class II
Status: Terminated
Initiated: 2014-06-11
Terminated: 2014-10-22
Firm location: Marquette, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K133785 — TRITIUM STERNAL CABLE PLATE SYSTEMPioneer Surgical Technology, Inc.·cleared 2014-01-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.