Home › MENTOR TEXAS L.P. › MENTOR MemoryGel Enhance Breast Implant
MENTOR MemoryGel Enhance Breast Implant
MENTOR TEXAS L.P. · Model SUHE1135 · UDI-DI 10081317031069
MRD
Prescription
10
510(k) clearances
287
Adverse events
4
Recalls
11
Facilities
Description
Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1135cc |Smooth|Round|Silicone|
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-06 | Allergan PLC | The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-l |
| 2015-06-08 | Allergan Inc | Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level. |
| 2014-12-11 | Mentor Texas, LP. | 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. |
| 2014-07-02 | Mentor Texas, LP. | The device labeling is stamped with 330cc and the device is actually 380cc device. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.