Orthofix Firebird Modular Screw Driver Recalled for Collet Malfunction
Orthofix is recalling 443 Modular Screw Drivers because the collet may malfunction, preventing effective screw placement and delaying surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a malfunction directly impacts surgical efficacy and duration, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Orthofix, Inc. is recalling 443 units of the Firebird Spinal Fixation System Instrumentation Modular Screw Driver (Part Number 52-1332). The recalled instrument is a reusable device used by surgeons to insert modular bone screws into the pedicle during spinal fixation procedures.
The recall was initiated after Orthofix received six complaints regarding reportable events where the screw driver's collet malfunctioned. This malfunction allegedly prevented surgeons from effectively placing the modular screws, which resulted in extended surgical times of more than 30 minutes and potential delays in the surgery.
The affected products were distributed worldwide, including the United States (including Puerto Rico), Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel. Healthcare facilities and users should stop using the affected instruments and contact Orthofix for instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Orthofix, Inc.
- Affected units
- 443
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Production Identification Numbers: Part Number 52-1332
- All Lot Numbers.
Distribution
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