Smith & Nephew recalls 4.5mm FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 devices with specific lot numbers due to potential displacement of the anchor tip protector, which could create a sterile breach during surgical procedures.
Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach.
Smith & Nephew is recalling certain models of their FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 devices because a gap between the device and its packaging might cause the anchor tip protector to move. This could lead to a sterile breach during surgery, which is a serious risk for patients.
The device may move excessively due to space between it and the packaging, causing the anchor tip protector to displace. This could create a sterile breach during surgery, which is a breach of the surgical site's sterile environment and risks infection or complications.
Surgical professionals who use Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 devices with the listed lot numbers are most at risk. Patients undergoing surgery with these devices could face a sterile breach.
Check the product label for the lot numbers listed in the recall: 2012020 through 2025342 and other specific numbers provided in the recall notice. The product is a 4.5mm FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 from Smith & Nephew.
Look for the lot numbers listed in the recall (e.g., 2012020, 2012021, etc.) on the device packaging or label.
If you have the recalled device, contact Smith & Nephew directly for further instructions on how to handle the device.
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 with specific lot numbers listed in the recall notice.
Check the product label for the lot numbers provided in the recall (e.g., 2012020, 2012021, etc.).
Contact Smith & Nephew directly for instructions on how to handle the device.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1756-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1756-2020 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.
