Orthofix Firebird Spinal Fixation System recall
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular…
Why was Orthofix Firebird Spinal Fixation System recalled?
Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the screw driver's collet would malfunction resulting in the surgeon being unable to use the Modular Screw Driver to effectively place Modular Screws, which may result in a delay of surgery.
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?
Production Identification Numbers: Part Number 52-1332, All Lot Numbers.
- Product
- Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular…
- Recalling firm
- Orthofix, Inc.
- Quantity
- 443
- Distribution
- Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.
- Recall date
- February 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)