Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response Recalled by OrthoPediatrics Corp Due to Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle...
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
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Quantity: 102
Why Was This Recalled?
Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.
Where Was This Sold?
This product was distributed to 20 states: AL, AZ, CA, DE, FL, GA, HI, KY, LA, MI, MN, MS, MO, NJ, NY, NC, OH, OR, TN, TX
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