MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile… — Class II medical device recall Z-0964-2015
Terminated recall by Mentor Texas, LP., reported 2015-01-21, distributed in CA, FL, GA, IL, KS, MA, ME, NC…. The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units
| Recall number | Z-0964-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mentor Texas, LP., Irving, TX, United States |
| Recall initiated | 2014-12-11 |
| Classified | 2015-01-13 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2016-01-04 |
| Distributed | CA, FL, GA, IL, KS, MA, ME, NC, NJ, NY, OR, PA, TN, TX, WA, WI, WV |
| Quantity | 45 units |
Product
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0964-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.