Device product
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
Z-2047-2014
Product summary
- Event
- Event 68565
- Status
- Terminated
- Classification
- Class II
- Quantity
- 907 units
- Official record key
device-enforcement:Z-2047-2014
Official wording
Reason: Sterility of device is compromised due to breach in sterile barrier
Code information: Lot Numbers: 50478982, 50478985, 50482873, 50485588, 50486705, 50486707, 50491897, 50491899
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
Derived failure modes
-
Sterility assurance
compromised due to breach in sterile barrier