Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Recalled by OrthoPediatrics Corp Due to The 7mm diameter uniaxial pedicle screws have been...
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 OrthoPediatrics Corp directly.
Affected Products
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
Quantity: 24 units
Why Was This Recalled?
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About OrthoPediatrics Corp
OrthoPediatrics Corp has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report