Z-0896-2013Class II

Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700)

Name: Z-0896-2013 Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700)
Creator: Orthofix, Inc
Published: 2013-02-01
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2013-02-01 / Terminated / root cause: design

FDA source

Orthofix, Inc began a recall of Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod... on 2013-02-01. FDA classified it as Class II and gives the reason as "There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0896-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-01
Posted: 2013-02-28
Terminated: 2013-07-01
Recalling firm: Orthofix SRL
Product: Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012.
Root cause tag: design
FDA root cause: Device Design
Action: Orthofix sent an Urgent Medical Device Recall Notification dated February 1, 2013 to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to identify and remove the affected products from inventory immediately and follow the actions listed in the enclosed Product Return Instructions. For questions or concerns contact Regulatory Affairs at 214-937-2100.
Quantity in commerce: 565 total (287 PN 52-6800 and 278 PN 52- 6700)
Distribution: Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.
Product codes and lots: Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0896-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0896-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-28

Product code KWP

K080407Class IIBlackstone Sfs Parallel Rod ConnectorsBlackstone Medical, Inc. / cleared 2008-03-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)