Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
3.5mm Locking Cortical Bone Screw Recalled by OrthoPediatrics Corp Due to OrthoPediatrics has initiated a Voluntary RECALL of Part...
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
3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.
Quantity: 12 units
Why Was This Recalled?
OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524.
Where Was This Sold?
This product was distributed to 8 states: CO, FL, KY, LA, MN, MO, OH, OK
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