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Mentor Texas, LP.: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (

Medical DevicesSource: FDA (device) · Date: 2026-04-08

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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: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
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
00081317006671 00081317006794 00081317006800
Voluntary mandated
Voluntary: Firm initiated
City
Irving
State
TX
Country
United States
Event id
98482
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