Mentor Texas, LP.: Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile T
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Mentor Texas, LP.
- Product
- Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
- Reason / hazard
- Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the countries of Canada, Albania, Australia, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Norway, Pakistan, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Czech Republic.
- Recall initiated
- 2026-02-18
- Code info
- UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Irving
- State
- TX
- Country
- United States
- Event id
- 98482
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