Data Foundry

Medical device recalls 2013

Firebird Spinal Fixation System — Class II medical device recall Z-0896-2013

Terminated recall by Orthofix, Inc, reported 2013-03-06, distributed nationwide. There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (

Recall numberZ-0896-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmOrthofix, Inc, Lewisville, TX, United States
Recall initiated2013-02-01
Classified2013-02-28
Reported by FDA2013-03-06
Terminated2013-07-01
DistributedNationwide (US)
Countries outside the USAU, DE, ES, IL, LB, SE
Reason classespackaging
Model numbers52-6700, 52-6800

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0896-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.