Smith & N: Legion PS High Flex XLPE Articular Insert Recall - Incorrect Part Packaging
Smith & Nephew recalls Legion PS High Flex XLPE size 5-6 9mm Articular Insert due to incorrect part packaging. Affected units may have improper components.
Lower-risk recall
LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
Contact the company
What happened, in plain English
Smith & Nephew is recalling Legion PS High Flex XLPE size 5-6 9mm Articular Inserts because they were packaged with an incorrect part. This could lead to improper function of the implant. Read more at govinfonow.com/recall/66257-smith-n-legion-ps-high-flex-xlpe-articular-insert-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/66257-smith-n-legion-ps-high-flex-xlpe-articular-insert-recall · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1507-2020
Cite this page
“Smith & N: Legion PS High Flex XLPE Articular Insert Recall - Incorrect Part Packaging.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/66257-smith-n-legion-ps-high-flex-xlpe-articular-insert-recall. Based on FDA recall #Z-1507-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1507-2020%22&limit=1).
Why it’s dangerous
The product was packaged with an incorrect part, which could result in improper implant function during surgery. This might cause complications if the implant does not fit correctly.
Who’s affected
Patients who received the recalled Legion PS High Flex XLPE Articular Insert (Lot 19FM12500) during surgery are likely affected. Surgeons and medical staff using the product are at risk of improper implant function.
How to tell if you have this one
Check for the product name 'Legion PS High Flex XLPE size 5-6 9mm Articular Insert' and lot number 19FM12500. The product was sold by Smith & Nephew, Inc.
- Brand
Smith & Nephew- Category
Medical device
What to do — step by step
Check Product Details
Verify the lot number and product number on the packaging to confirm if it matches the recalled item.
Where it went and when
Where it was distributed
Distributed in 10 states and Puerto Rico, and outside the U.S.
FDA distribution: “USA: TN, NC, CA,OR, NM, TX, PA, MI, LA, DA, IL. Int'l: IT (Italy), NL (Netherlands), RO (Romania), PR (Puerto Rico).” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois, Louisiana, Michigan, New Mexico, North Carolina, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas.
Recall timeline
FDA terminated this recall 4.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-1507-2020 (December 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1507-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.