Z-1625-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- February 12, 2018
- Termination Date
- April 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Reason for Recall
Potential for Capio sutures to break and /or detach.
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.
Code Information
GTIN: 08714729784449. Batch number: ML00002919