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MENTOR Smooth Round Moderate Profile
MENTOR TEXAS L.P. · Model 3501620D · UDI-DI 10081317030581
FWM
Prescription
0
510(k) clearances
118,309
Adverse events (75 deaths)
9
Recalls
8
Facilities
Description
Saline Breast Implant, 175cc |Smooth|Round|Saline|
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-30 | Mentor Texas, LP. | Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device. |
| 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 |
| 2019-07-24 | Allergan PLC | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho |
| 2019-03-18 | Ideal Implant Incorporated | The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation. |
| 2017-03-27 | Mentor Texas, LP. | Missing Dome Pack accessory. |
| 2005-12-14 | Inamed Corp | Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched |
| 2005-12-14 | Inamed Corp | Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched |
| 2005-05-05 | Inamed Corp | Wrong size implant was mislabeled. |
| 2003-08-01 | Inamed Corp | Labeling mixup. |
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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.