Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver i
FDA device recall Z-0855-2014 · posted 2014-01-28 · Terminated
Recall details
- Recalling firm
- Orthofix, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 443
- Distribution
- Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.
- Date initiated
- 2013-11-26
- Date posted
- 2014-01-28
- Date terminated
- 2014-12-09
- Location
- Lewisville, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLACKSTONE PEDICLE SCREW SYSTEM (K081684) | Blackstone Medical, Inc. | 2008-09-15 |