Z-0855-2014Class II

Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver

Name: Z-0855-2014 Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver
Creator: Orthofix, Inc.
Published: 2013-11-26
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2013-11-26 / Terminated / root cause: manufacturing process

FDA source

Orthofix, Inc. began a recall of Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone... on 2013-11-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0855-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-26
Posted: 2014-01-28
Terminated: 2014-12-09
Recalling firm: Orthofix SRL
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.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 443
Distribution: Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.
Product codes and lots: Production Identification Numbers: Part Number 52-1332, All Lot Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0855-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0855-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28

Product code KWP

K081684Class IIBlackstone Pedicle Screw SystemBlackstone Medical, Inc. / cleared 2008-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)