Class II — Mentor Texas, LP.
| Recalling firm | MENTOR Texas, LP |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer. |
| Product | MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer. |
| Quantity | 45 units |
| Distribution | US Distribution to the states of : MA, WV, NY, FL, ME, NC, TX, IL, KS, TN, NJ, PA, CA, OR, WI, GA, and WA |
| Initiated | 2014-12-11 |
| Classified | 2015-01-13 |
| Terminated | 2016-01-04 |
| Recall number | Z-0964-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Mentor Texas, LP. (Z-0964-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70042/
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