Recall Z-0855-2014 ยท KWP Appliance, Fixation, Spinal Interlaminal
Orthofix, Inc.
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
| Date | Jan 28, 2014 (initiated Nov 26, 2013) |
| Status | Terminated |
| Reason | Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the screw driver's collet would malfunction resulting in the surgeon being unable to use the Modular Screw Driver to effectively place Modular Screws, which may result in a delay of surgery. |
| Root cause | Nonconforming Material/Component |
| Action | Orthofix sent an Urgent Medical Device Recall Notification letter dated November 26, 2013 by certified mail to distributors. The letter identified the affected product, problem and actions to be taken. The letter instructed distributors to immediately cease any further distribution, return affected products to Orthofix at no cost and complete the attached reply form. For questions contact your local Orthofix representative. |
| Quantity | 443 |
| Distribution | Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081684 | BLACKSTONE PEDICLE SCREW SYSTEM Blackstone Medical, Inc., Sep 15, 2008 |