Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: Recalled by Orthohelix Surgical Designs Inc Due to The tips of the drivers are breaking while...
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 Orthohelix Surgical Designs Inc directly.
Affected Products
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Quantity: 120 Pieces
Why Was This Recalled?
The tips of the drivers are breaking while being used to drive the screws into patients.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Orthohelix Surgical Designs Inc
Orthohelix Surgical Designs Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report