Smith & Nephew recalls specific sutures due to packaging that may allow sterile barrier breaches. Affected batches include 7211015 with batch numbers 50498479-50603355. Stop using if you have these items.
Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.
Smith & Nephew is recalling certain sutures because the packaging might have pin holes that could breach the sterile barrier. This could lead to infections if the sutures are used without proper sterility.
The packaging may have pin holes that allow contamination of the sterile Tyvek film. This could breach the sterile barrier during use, increasing infection risk if the sutures are not properly sterilized.
Surgical patients and medical professionals who use the recalled sutures. Those with the specific batch numbers listed are most at risk.
Check for the product name 'Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures' with the part number 7211015 and batch numbers listed in the recall notice.
Look for the part number 7211015 and batch numbers 50498479 through 50603355 on the packaging.
The packaging may have pin holes that could breach the sterile barrier, increasing infection risk during surgical procedures.
Check for the part number 7211015 and batch numbers 50498479-50603355 on the packaging.
The recall does not specify a remedy, so contact Smith & Nephew for guidance.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1536-2018 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1536-2018 from Smith & Nephew. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
