Smith & Nephew recalls BIORAPTOR suture anchors due to packaging design flaws that could breach sterile barriers. Affected units include specific part numbers and batch dates. Consumers should contact the company for details.
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Smith & Nephew is recalling BIORAPTOR suture anchors because their packaging might not hold the device's shape, risking a sterile barrier breach. This could lead to infection or other complications during surgery.
The packaging design is inadequate, meaning it might not maintain the device's shape during handling. This could cause a breach in the sterile barrier, potentially leading to infection or other complications during surgery.
Surgical patients and medical professionals who use these suture anchors. Those with the specific part numbers or batch dates listed are most at risk.
Check for part numbers 72201541, 72201542, 72203280, or 72203281. Also look for batch numbers 2146369, 2151242, 2151690, 2154691, 2153489, or 2151692.
Identify your BIORAPTOR suture anchor's part number and batch date to confirm if it's affected.
Reach out to Smith & Nephew for specific instructions on how to handle the affected product.
Part numbers 72201541, 72201542, 72203280, and 72203281.
Batch numbers 2146369, 2151242, 2151690, 2154691, 2153489, and 2151692.
Check for the specific part numbers or batch dates listed in the recall notice.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0581-2025 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0581-2025 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.
