Device product
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
Z-2136-2014
Product summary
- Event
- Event 68863
- Status
- Terminated
- Classification
- Class II
- Quantity
- A total of 5-pieces of each part number distributed
- Official record key
device-enforcement:Z-2136-2014
Official wording
Reason: Revision B of the tissue shields of the device was 7 mm longer than the previous design.
Code information: Part numbers X079-0096 and X079-0097 with Lot #12320
Distribution pattern: US Distribution including the states of FL and MO.
Derived failure modes
-
Unknown
Revision B of the tissue shields of the device was 7 mm longer than the previous design.