Device product
TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor
Z-2232-2013
Product summary
- Event
- Event 66037
- Status
- Terminated
- Classification
- Class II
- Quantity
- 708 US
- Official record key
device-enforcement:Z-2232-2013
Official wording
Reason: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Code information: 50325165 50326838 50336722 50339646 50339844 50343443 50350417 50352981 50379206 50397701 50429644
Distribution pattern: Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
Derived failure modes
-
Sterility assurance
breach of the sterile barrier