International safety notice
Urgent field safety notice for Advantage and Advantage Fit System (Transvaginal Sling) / Lynx System (Suprapubic Sling) / Obtryx System (Curved or Halo; Transobturator Sling) / Obtryx II System with PrecisionBlue Design (Curved or Halo; Transobturator Sling) / Solyx SIS System (Single Incision Sling) / Uphold LITE Vaginal Support System with Capio SLIM / Pinnacle LITE Pelvic Floor Repair Kit (Posterior with Capio SLIM) / Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device, Boston Scientific International S.A.
Germany / BfArM · DEU · Jun 13, 2016
Key facts
| Title | Urgent field safety notice for Advantage and Advantage Fit System (Transvaginal Sling) / Lynx System (Suprapubic Sling) / Obtryx System (Curved or Halo; Transobturator Sling) / Obtryx II System with PrecisionBlue Design (Curved or Halo; Transobturator Sling) / Solyx SIS System (Single Incision Sling) / Uphold LITE Vaginal Support System with Capio SLIM / Pinnacle LITE Pelvic Floor Repair Kit (Posterior with Capio SLIM) / Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device, Boston Scientific International S.A. |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | Advantage and Advantage Fit System (Transvaginal Sling) / Lynx System (Suprapubic Sling) / Obtryx System (Curved or Halo; Transobturator Sling) / Obtryx II System with PrecisionBlue Design (Curved or Halo; Transobturator Sling) / Solyx SIS System (Single Incision Sling) / Uphold LITE Vaginal Support System with Capio SLIM / Pinnacle LITE Pelvic Floor Repair Kit (Posterior with Capio SLIM) / Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device, Boston Scientific International S.A. |
| Manufacturer | Urgent field safety notice for Advantage and Advantage Fit System (Transvaginal Sling) / Lynx System (Suprapubic Sling) / Obtryx System (Curved or Halo; Transobturator Sling) / Obtryx II System with PrecisionBlue Design (Curved or Halo; Transobturator Sling) / Solyx SIS System (Single Incision Sling) / Uphold LITE Vaginal Support System with Capio SLIM / Pinnacle LITE Pelvic Floor Repair Kit (Posterior with Capio SLIM) / Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device, Boston Scientific International S.A. |
| Models | M0068507001, 93420, M0068504110, M0068503001, M0068505110, 5-PACK, M0068318220, M0068505001, 95941, M0068505111, M0068318170, M0068504000 and 15 more |
| Date | Jun 13, 2016 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1