Device product
SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
Z-2049-2014
Product summary
- Event
- Event 68565
- Status
- Terminated
- Classification
- Class II
- Quantity
- 763 units
- Official record key
device-enforcement:Z-2049-2014
Official wording
Reason: Sterility of device is compromised due to breach in sterile barrier
Code information: Lot Numbers: 50478984,50485736, 50485737, 50485738, 50487831, 50491901, 50493684
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