Orthofix Firebird Spinal Fixation System Instrumentation… recallZ-0855-2014 · Orthofix, Inc. · initiated Nov 26, 2013
Class II Terminated All recalls posted in January 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Orthofix, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0855-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 26, 2013
- Posted by the FDA
- Jan 28, 2014
- Recalling firm
- Orthofix, Inc.
- Quantity
- 443
- Product code
- KWP
- FDA submissions
- K081684
- Distribution
- Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.
Product description
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.
Code information (models, lots, serial numbers)
Production Identification Numbers: Part Number 52-1332, All Lot Numbers.
Other devices under the same FDA submission
3 devices cleared under K081684 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FIREBIRD 44-2001Orthofix US LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 reports
- FIREBIRD 44-2101Orthofix US LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- FIREBIRD 77-8645Orthofix US LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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