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.
This recall has been terminated (originally issued January 28, 2014).
- Company
- Orthofix, Inc
- Recall Initiated
- November 26, 2013
- Posted
- January 28, 2014
- Terminated
- December 9, 2014
- Recall Number
- Z-0855-2014
- Quantity
- 443
- Firm Location
- Lewisville, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.
Lot / Code Info
Production Identification Numbers: Part Number 52-1332, All Lot Numbers.
Root 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.