Smith & Nephew Inc. is recalling 9,266 units of Rotation Medical Tendon Staples because of a defect in the packaging process. The outer foil pouch surrounding the inner Tyvek pouch may have an improper or incomplete seal, which could compromise the sterility of the medical device. These staples are used for the fixation of prosthetic material to soft tissues and were distributed worldwide between August 2024 and September 2024. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding affected devices.
An incomplete seal on the packaging can allow contaminants to enter the pouch, potentially introducing bacteria or other pathogens to a device that must remain sterile. Using a non-sterile device during a surgical procedure poses a risk of infection or other serious health complications for the patient.
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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