Biodesign Inguinal Hernia Graft Recall Due to Premature Expiration
Cook Biotech is recalling Biodesign Inguinal Hernia Graft units because products expire before their labeled expiration date, potentially affecting surgical outcomes.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall of a surgical implant with a device expiration defect. No illnesses, injuries, or deaths have been reported. The hazard is a real defect affecting device function, but without documented patient harm.
Plain-English summary
Cook Biotech is recalling 120 units of Biodesign Inguinal Hernia Graft C-IHM-10X15 worldwide, including distribution throughout the United States, Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, and South Africa.
The affected products expire prior to the expiration date printed on the product labeling. This graft is used during hernia repair surgery to reinforce soft tissue in the inguinal floor. Devices that expire before their labeled expiration date may not maintain their intended structural and functional properties.
If you are a healthcare provider or facility that received these affected lots, do not use them for patient procedures. Surgeons and hospital staff should contact Cook Biotech for instructions on returning the affected devices. Patients who have already had these devices implanted should consult with their surgeon about monitoring or any necessary follow-up care.
The recalled product
- Product
- Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
- Manufacturer
- Cook Biotech, Inc.
- Hazard
- device-defect
- expiration-defect
Distribution
Distributed nationwide across the United States.
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