Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended Recalled by Orthofix, Inc Due to There is a possibility that the device may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Orthofix, Inc directly.
Affected Products
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
Quantity: 36 units
Why Was This Recalled?
There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.
Where Was This Sold?
Worldwide Distribution -- US, Spain, Italy, and Australia.
About Orthofix, Inc
Orthofix, Inc has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report