NewDeal TIBIAXYS Medical Device Recalled Due to Infection Risk
NewDeal SA is recalling TIBIAXYS devices because use may cause superficial or deep infections requiring antibiotic treatment or device removal.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (infection requiring antibiotics or device removal) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
NewDeal SA is recalling TIBIAXYS medical devices, including specific model numbers and lot numbers, due to a risk of infection. The recall covers devices distributed to 19 states, including California, Colorado, and New York.
The source text states that use of the impacted product may cause a superficial infection requiring oral antibiotics and wound care, or a deep infection requiring intravenous antibiotics and device removal. No specific number of affected units or reported illnesses is provided in the source text.
Consumers and healthcare providers should stop using the affected TIBIAXYS devices and contact NewDeal SA for instructions on return or replacement.
The recalled product
- Product
- 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
- Manufacturer
- NewDeal SA
- Hazard
Distribution
Part of a larger recall action
This product is one of 5 recalled by NewDeal SA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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