Orthofix, Inc: Medical Device Recall in 2013 - (Recall #: Z-0896-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 1, 2013

Date Posted: March 6, 2013

Recall Number: Z-0896-2013

Event ID: 64265

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.

Status: Terminated

Product Quantity: 565 total (287 PN 52-6800 and 278 PN 52- 6700)

Code Information:

Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers

Distribution Pattern:

Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.

Voluntary or Mandated:

Voluntary: Firm initiated