Reported Feb 5, 2014 · Terminated
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver…
Orthofix, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthofix, Inc. · 3451 Plano Pkwy · Lewisville, TX · 75056-9453
Is this the product you have?
- Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver
- Product UsageThe Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument
- Lot codes and dates
- Production Identification NumbersPart Number 52-1332, All Lot Numbers
- Amount recalled
- 443
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
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