Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Integra External Fixation System Rocker Bottom Model # 12225400. For Recalled by Integra LifeSciences Corp. Due to The silicone insert embedded in the rocker bottom...
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 Integra LifeSciences Corp. directly.
Affected Products
Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
Quantity: 27 units
Why Was This Recalled?
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
Where Was This Sold?
This product was distributed to 6 states: CO, FL, IN, OK, VA, DC
About Integra LifeSciences Corp.
Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report