Recall Z-2573-2014— PIONEER SURGICAL TECHNOLOGY, INC.

Name: FDA recall Z-2573-2014
Creator: U.S. Food and Drug Administration
Published: 2012-09-10

Class II · Terminated

Class II FDA medical device recall by PIONEER SURGICAL TECHNOLOGY, INC., initiated 2012-09-10, terminated 2014-09-30. It names one FDA 510(k) clearance: K112757. Product: STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY. Reason: Some set screw thread profiles were found not to be within specifications..

Recalling firm: PIONEER SURGICAL TECHNOLOGY, INC.
Classification: Class II
Status: Terminated
Initiated: 2012-09-10
Terminated: 2014-09-30
Firm location: Marquette, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K112757 — PIONEER POSTERIOR CERVICO THORACIC SYSTEMPioneer Surgical Technology, Inc.·cleared 2012-03-12

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

STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY

Reason for recall

Some set screw thread profiles were found not to be within specifications.

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