LiquiBandFIX8® Open Hernia Mesh Fixation Device
Brand(s)
Last updated
Summary
Product
LiquiBandFIX8® Open Hernia Mesh Fixation Device
Issue
Medical devices - Premature failure
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected Products | Lot or Serial Number | Model or catalog number |
|---|---|---|
| LiquiBandFIX8® Open Hernia Mesh Fixation Device | P00221182, P00221313, P00221396, P00221600, P00221756, P00221983, P00225605, P00225801, P00226740 | FX002 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
Advanced Medical Solutions Ltd.
Plymouth, Devon
United Kingdom, PL7 5BG
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type III
Identification number
RA-63914
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