Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TIBIAXYS Recalled by NewDeal SA Due to Use of the impacted product may cause a...
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 NewDeal SA directly.
Affected Products
TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S
Why Was This Recalled?
Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
Where Was This Sold?
This product was distributed to 19 states: CA, CO, CT, ID, KS, MD, MA, MN, MS, MO, NY, NC, OH, OR, PA, SD, VA, WA, WI
About NewDeal SA
NewDeal SA has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report