Recall Z-0855-2014
Orthofix, Inc. · initiated November 26, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
Codes / lots: Production Identification Numbers: Part Number 52-1332, All Lot Numbers.
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Orthofix sent an Urgent Medical Device Recall Notification letter dated November 26, 2013 by certified mail to distributors. The letter identified the affected product, problem and actions to be taken. The letter instructed distributors to immediately cease any further distribution, return affected products to Orthofix at no cost and complete the attached reply form. For questions contact your local Orthofix representative.
Details
- Recall number
- Z-0855-2014
- Initiated
- November 26, 2013
- Posted by FDA
- January 28, 2014
- Terminated
- December 9, 2014
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 443
- Distribution
- Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.
- Recalling firm
- Orthofix, Inc., Lewisville, TX