Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MaxLock Extreme Mod-Foot Concave Reamer Recalled by Orthohelix Surgical Designs Inc Due to Incorrect sizing was being laser etched on the...
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
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
Quantity: 38
Why Was This Recalled?
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
Where Was This Sold?
This product was distributed to 12 states: MI, MO, NM, NC, OH, PA, TN, TX, UT, VA, WA, WI
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