Device product
TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor
Z-2240-2013
Product summary
- Event
- Event 66037
- Status
- Terminated
- Classification
- Class II
- Quantity
- 314 US
- Official record key
device-enforcement:Z-2240-2013
Official wording
Reason: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Code information: 50373721 50375642 50397595 50397598 50397604 50397607 50449548
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