Ethicon, LLC has recalled approximately 94,788 units of PROLENE Polypropylene, PERMA-HAND Silk, and ETHIBOND EXCEL Polyester sutures due to a manufacturing defect that may have left an open seal on the primary packaging. This breach in the packaging seal could compromise the sterility of the medical device and introduce pathogens to patients during surgery. The affected products were distributed worldwide through hospital supply channels and surgical centers.
If the sterile seal of a suture is open or compromised, bacteria and other pathogens can enter the packaging and cause serious infections at the surgical site. While no injuries have been reported, these sutures are used in sensitive procedures including cardiovascular, ophthalmic, and neurosurgical operations where sterility is critical.
Indicated for general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurosurgical procedures.
Indicated for general soft tissue approximation and/or ligation.
Model W8003T noted as not sold in the US.
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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