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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Related recalls
Same manufacturer · Orthofix, Inc.
See all →- HighOrthofix Non-Locking Screws Recalled Due to Failure to Engage Plates
FDA (Devices) · 2018-06-13
- SevereOrthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
- HighOrthofix Recalls Non-Locking Screws Due to Failure to Engage Plates
FDA (Devices) · 2018-06-13
- SevereOrthofix Recalls Rival Plating Systems Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
- SevereOrthofix Recalls MTP Plates Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- HighOrthofix Firebird NXG Spinal Fixation Set Screw Driver Recalled
FDA (Devices) · 2016-06-08
- ModerateOrthofix Firebird Spinal Fixation System Recalled for Mislabeling
FDA (Devices) · 2015-06-17
- SevereOrthofix Firebird Spinal Fixation System Rod Connectors Recalled for Cracking Risk
FDA (Devices) · 2013-03-06
- HighOrthofix Firebird Spinal Fixation System Torque Limiting Handle Recall
FDA (Devices) · 2016-02-17
- HighOrthofix Firebird NXG Decorticating Planer Recalled for Missing Plastic Core
FDA (Devices) · 2017-09-20
- HighOrthoPediatrics Recalls Response Spine Pedicle Screws Due to Manufacturing Defect
FDA (Devices) · 2016-01-20