Corin Ltd is recalling four units of Unity CR Femur and Unity Total Knee Systems because of a labeling error. Specifically, Unity CR Inserts Right size 6 from batch 529803 may be incorrectly labeled as size 7 from batch 532405, and vice versa. Using an incorrectly sized insert during a total knee arthroplasty (knee replacement surgery) can lead to improper joint fit and potential surgical complications. These products were distributed to medical facilities in Michigan, Texas, and Illinois.
The mismatch between the label and the actual size of the surgical insert can lead to the installation of an incorrectly sized component during surgery. This can result in joint instability, poor surgical outcomes, or the need for revision surgery to correct the size discrepancy.
Contact healthcare provider or manufacturer
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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