Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Intraosseous Fixation System (IFS) 1.7 mm Recalled by Orthohelix Surgical Designs Inc Due to The firm was notified by a customer that...
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
Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
Quantity: Lot # 2399041, 97 pcs; Lot # 2399051, 143 pcs; Lot # 2399051R, 4 pcs & Lot # 2399061, 119 pcs
Why Was This Recalled?
The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.
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