Total Joint Orthopedics, Inc. has recalled 103 units of the Klassic BiPolar Head orthopedic implant due to a potential packaging issue that could compromise the sterile barrier. A defect in the packaging may cause the device to lose its sterility, which is essential for any product implanted during surgery. If a non-sterile device is used, it presents a significant risk of infection for the patient.
A compromised sterile barrier allows bacteria or other contaminants to reach the implant. If used in surgery, this can lead to severe post-operative infections at the surgical site, potentially requiring additional medical treatment or revision surgery.
Quantity: 103 units affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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