Device product
OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
Z-2227-2013
Product summary
- Event
- Event 66037
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4946 US
- Official record key
device-enforcement:Z-2227-2013
Official wording
Reason: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Code information: 50366964 50366974 50366982 50366987 50366991 50370758 50370941 50370943 50371293 50376477 50387447 50392962 50394696 50397924 50400302 50400308 50408067 50414256 50415787 50417207 50419579 50425118 50428815 50429654 50431732 50435075 50435211 50444669 50445035 50445761 50445877 50450950 50458418 50458435
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