FDA Device recall Z-0964-2015
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer
- FDA Device
- Class II
- terminated
- Published 2015-01-21
On 2015-01-21 the FDA classified a Class II recall of MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer by Mentor Texas, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0964-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-11 |
| Published | 2015-01-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mentor Texas |
| Distribution | CA, FL, GA, IL, KS, MA, ME, NC, NJ, NY, OR, PA, TN, TX, WA, WI, WV |
Product
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
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.
Identifiers
| code_info | 6790747-030, 6684051-002, 6685063-013, 6728126-044, 6822437-031, 6685063-011, 6728128-035, 6702298-031, 6838011…6790747-030, 6684051-002, 6685063-013, 6728126-044, 6822437-031, 6685063-011, 6728128-035, 6702298-031, 6838011-018, 6733863-003, 6733863-017, 6701421-023, 6696938-022, 6824389-004, 6719893-016, 6687714-031, 6834854-016, 6839585-001, 6849927-019, 6675404-028, 6684051-031, 6803156-029, 6838011-020, 6825406-014, 6751554-012, 6741590-026, 6830995-006, 6721250-014, 6694754-031, 6707932-006, 6789276-002, 6790619-029, 6821980-010, 6853040-025, 6691833-020, 6715539-004, 6836766-012, 6683549-030, 6703183-005, 6789532-021, 6789191-001, 6848592-012, 6790747-028, 6833028-030, 6723961-006, 6716622-011, 6742458-008, 6684051-026, 6685067-008, 6703784-036, 6748082-029, 6748820-019, 6822436-028, 6827017-004, 6829287-016, 6834856-021, 6825200-001, 6701421-034, 6716223-011, 6794993-017, 6723958-007, 6723958-011, 6723957-042. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0964-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.