NewDeal SA recalls TIBIAXYS devices with specific model numbers and lots due to risk of infection requiring antibiotics. Affected users should contact NewDeal for remedy details.
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.
NewDeal SA is recalling specific TIBIAXYS models that may cause infections needing antibiotics. This is serious but not immediately life-threatening.
The device may cause superficial infections requiring oral antibiotics or deeper infections needing intravenous antibiotics and device removal. This happens due to the device's design allowing bacteria entry.
Users of the TIBIAXYS devices with model numbers listed and corresponding lots are affected. Those with open wounds or recent infections are at higher risk.
Check your TIBIAXYS device for model numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S, or 150516S. Also check the lot numbers listed for each model.
Identify your TIBIAXYS model number from the list provided in the recall notice.
Reach out to NewDeal SA for specific remedy instructions based on your model and lot number.
The affected models are 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S, and 150516S.
Contact NewDeal SA directly for remedy instructions based on your specific model and lot number.
The recall states a risk of infection requiring antibiotics, but not serious injury like death or major trauma. This is a medical risk, not a physical hazard.
We’ve drafted a message you can send NewDeal to request your refund or repair — edit it as you like.
Subject: Recall Z-2447-2018 — NewDeal NewDeal Hello, I own a NewDeal that is covered by recall Z-2447-2018 from NewDeal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
