Ethicon Endo Surgery, LLC is recalling 41,508 units of various surgical sutures and needles, including PDS PLUS, PDS II, PROLENE BLU, and ETHIBOND EXCEL, due to a manufacturing defect where the silicone coating on the needles did not cure properly. This issue was identified during the needle manufacturing process and could affect how the needles perform during surgery. No injuries or incidents have been reported at this time.
Improperly cured silicone on surgical needles may affect the needle's ability to penetrate tissue smoothly or could lead to silicone material residues in the surgical site, potentially complicating surgical procedures or affecting patient outcomes.
GMDN: 47362
GMDN: 16584
GMDN: 13909
GMDN: 13906
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.
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Sources: FDA iRES · Raw API Response
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