FDA-Device2026-04-08Class II

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc

Mentor Texas, LP.

Hazard

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Sold states

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.

Manufactured in

3041 Skyway Cir N, Irving, TX, United States

Products

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1682-2026

Original summary

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. 10081317028335 Distribution: 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.

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