Firebird Spinal Fixation System recall
Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for…
Why was Firebird Spinal Fixation System recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers
- Product
- Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for…
- Recalling firm
- Orthofix, Inc
- Quantity
- 565 total (287 PN 52-6800 and 278 PN 52- 6700)
- Distribution
- Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.
- Recall date
- March 6, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)