Class II — Orthofix, Inc
| Recalling firm | ORTHOFIX SRL |
|---|---|
| Registered facility | ORTHOFIX SRL (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 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. |
| Initiated | 2013-02-01 |
| Classified | 2013-02-28 |
| Terminated | 2013-07-01 |
| Recall number | Z-0896-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Orthofix, Inc (Z-0896-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64265/
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