Orthofix Firebird Spinal Fixation System Instrumentation Modular… — Class II medical device recall Z-0855-2014
Terminated recall by Orthofix, Inc., reported 2014-02-05, distributed nationwide. Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater th
| Recall number | Z-0855-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix, Inc., Lewisville, TX, United States |
| Recall initiated | 2013-11-26 |
| Classified | 2014-01-28 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2014-12-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CO, DE, ES, IL, MX, PE, ZA |
| Quantity | 443 |
| Reason classes | device malfunction |
| Model numbers | 52-1332 |
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.
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.
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-0855-2014. 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.