Recall Z-0896-2013 ยท KWP Appliance, Fixation, Spinal Interlaminal
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.
| Date | Feb 28, 2013 (initiated Feb 1, 2013) |
| 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080407 | BLACKSTONE SFS PARALLEL ROD CONNECTORS Blackstone Medical, Inc., Mar 13, 2008 |