During verification testing, a non-conformance was detected. Failure mode was uncontrolled leakage of glue from the distal tip of the Fix8 Open (FX002) device. Recall start date: Feb 3, 2022
Hazard description
Premature failure
Product
Product name
LiquiBandFIX8® Open Hernia Mesh Fixation Device
Reference
ID
RA-63914
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