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Recall Observatory FDA recall evidence

Device product

PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Z-1625-2018

February 12, 2018

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 79608
Status
Terminated
Classification
Class II
Quantity
24
Official record key
device-enforcement:Z-1625-2018

Official wording

Reason: Potential for Capio sutures to break and /or detach.

Code information: GTIN: 08714729784449. Batch number: ML00002919

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

    reason.no_named_rule · v1.0.0

    Potential for Capio sutures to break and /or detach.