Firebird Spinal Fixation System, Parallel Rod Connector… recallZ-0896-2013 · Orthofix, Inc · initiated Feb 1, 2013
Class II Terminated All recalls posted in February 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Orthofix, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0896-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 1, 2013
- Posted by the FDA
- Feb 28, 2013
- Recalling firm
- Orthofix, Inc
- Quantity
- 565 total (287 PN 52-6800 and 278 PN 52- 6700)
- Product code
- KWP
- FDA submissions
- K080407
- Distribution
- Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.
Product description
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.
Code information (models, lots, serial numbers)
Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers
Other devices under the same FDA submission
2 devices cleared under K080407 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SFS;SFS LE;SFS SCOLI 56-3635Orthofix US LLC · Orthosis, spinal pedicle fixation1 report
- SFS;SFS LE;SFS SCOLI 56-3750Orthofix US LLC · Orthosis, spinal pedicle fixation1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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