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.
FDA Recall Z-0896-2013 · Posted 2013-02-28
Advertisement
Recalling FirmOrthofix, Inc
Recall StatusTerminated
Product CodeKWP
Date Initiated2013-02-01
Date Terminated2013-07-01
Product Quantity565 total (287 PN 52-6800 and 278 PN 52- 6700)
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement