Mentor Texas, LP.: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH
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
- CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc
- 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
- 10081317028359 10081317028366 10081317028373 10081317028380 10081317028397 10081317028403
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Irving
- State
- TX
- Country
- United States
- Event id
- 98482
Free daily digest + "My products" watchlist