Home › Establishment Labs S.A. › Motiva® SmoothSilk® Round Breast Implant
Motiva® SmoothSilk® Round Breast Implant
Establishment Labs S.A. · Model RSF-450+ · UDI-DI 07445161002143
FTR
Prescription
0
510(k) clearances
231,867
Adverse events (138 deaths)
14
Recalls
8
Facilities
Description
Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 450 cc
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 |
| 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 |
| 2019-07-24 | 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 |
| 2019-07-24 | 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 |
| 2019-07-24 | 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 |
| 2019-07-24 | 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 |
| 2019-07-24 | 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 |
| 2019-07-24 | 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 |
| 2019-07-24 | 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 |
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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.