Smith & Nephew BIORAPTOR Suture Anchors: Packaging Breach Risk
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.
Use caution until it’s fixed
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/53623-smith-nephew-bioraptor-suture-anchors-packaging-breach-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/53623-smith-nephew-bioraptor-suture-anchors-packaging-breach-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0581-2025
Cite this page
“Smith & Nephew BIORAPTOR Suture Anchors: Packaging Breach Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53623-smith-nephew-bioraptor-suture-anchors-packaging-breach-risk. Based on FDA recall #Z-0581-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0581-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Surgical patients and medical professionals who use these suture anchors. Those with the specific part numbers or batch dates listed are most at risk.
How to tell if you have this one
Check for part numbers 72201541, 72201542, 72203280, or 72203281. Also look for batch numbers 2146369, 2151242, 2151690, 2154691, 2153489, or 2151692.
- Brand
Smith & Nephew- Category
Medical device
What to do — step by step
Check Product Details
Identify your BIORAPTOR suture anchor's part number and batch date to confirm if it's affected.
Contact Smith & Nephew
Reach out to Smith & Nephew for specific instructions on how to handle the affected product.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Illinois, Indiana, Kentucky, Maryland, Minnesota, Nebraska, New Hampshire, New Jersey, North Carolina, Texas.
Recall timeline
FDA published this recall 43 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0581-2025 (October 29, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0581-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.