Orthofix, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0855-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 26, 2013

Date Posted: February 5, 2014

Recall Number: Z-0855-2014

Event ID: 66969

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.

Status: Terminated

Product Quantity: 443

Code Information:

Production Identification Numbers: Part Number 52-1332, All Lot Numbers.

Distribution Pattern:

Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.

Voluntary or Mandated:

Voluntary: Firm initiated