Device product
Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Z-1626-2018
Product summary
- Event
- Event 79608
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,002
- Official record key
device-enforcement:Z-1626-2018
Official wording
Reason: Potential for Capio sutures to break and /or detach.
Code information: GTIN: 08714729773955. Batch numbers: ML00002892 ML00003166 ML00003060 ML00003291 ML00003119 ML00003435 ML00003516
Distribution pattern: Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.
Derived failure modes
-
Unknown
Potential for Capio sutures to break and /or detach.