FDA Medical Device Recalls (openFDA)
Orthofix, Inc: 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.
- Recall number
- Z-0896-2013
- Recalling firm
- Orthofix, Inc
- 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.
- Status
- Terminated
- Initiated
- 2013-02-01
- Posted
- 2013-02-28
- Terminated
- 2013-07-01
- 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.
- Root cause
- Device Design
- Action
- 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.
- 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.
- Lot, serial or model codes
- Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers
- 510(k) numbers
- ["K080407"]
- PMA numbers
- not on file
- Product code
- KWP
- Firm FEI
- 2183449
- Firm city
- Lewisville
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28