Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 6, 2013
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.
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 fin…
Orthofix, Inc recalled Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector… - a moderate-severity action.
Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector… was recalled by Orthofix, Inc in March 6, 2013. Reason: There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly …. Check the official notice for the remedy. Verify recall #Z-0896-2013 with the FDA Devices before acting.
The recall
Orthofix, Inc issued this moderate-severity FDA Devices recall-There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly ….
- Moderate
- severity level
- Class II
- classification
- March 6, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0896-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0896-2013) was formally reported on March 6, 2013, with the manufacturer initiating the action on February 1, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Orthofix, Inc is listed as the recalling firm, operating out of Lewisville, TX. Federal records list the affected scope as 565 total (287 PN 52-6800 and 278 PN 52- 6700).
The documented reason for this recall is: 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 si… Distribution data in the federal record shows the product reached: Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
565 total (287 PN 52-6800 and 278 PN 52- 6700)
Related Recalls
6
3 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0896-2013 |
| Date reported | March 6, 2013 |
| Date initiated | February 1, 2013 |
| Recalling firm | Orthofix, Inc |
| Firm location | Lewisville, TX |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0896-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Orthofix, Inc. Units affected: 565 total (287 PN 52-6800 and 278 PN 52- 6700).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2013. Severity: Moderate. Recall number: Z-0896-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0896-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 6, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.