FDAFDA · Food and drugs·Recall number Z-0896-2013
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.
Published March 6, 2013 · Recall initiated: February 1, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Orthofix, Inc
- Distributor
- Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.
- Lot
- Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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