Recall Z-0896-2013— Orthofix, Inc

Name: FDA recall Z-0896-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-01

Class II · Terminated

Class II FDA medical device recall by Orthofix, Inc, initiated 2013-02-01, terminated 2013-07-01. It names one FDA 510(k) clearance: K080407. Product: Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.. Reason: There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012..

Recalling firm: Orthofix, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-02-01
Terminated: 2013-07-01
Firm location: Lewisville, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K080407 — BLACKSTONE SFS PARALLEL ROD CONNECTORSBlackstone Medical, Inc.·cleared 2008-03-13

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

Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.

Reason for recall

There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012.

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