Smith & Nephew Legion L-Wedge: 5mm screws instead of 10mm
Smith & Nephew recalls Legion L-Wedge Size 4 knee implants with 5mm screws instead of required 10mm screws. This mismatch risks improper joint fixation during surgery.
Use caution until it’s fixed
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Contact the company
What happened, in plain English
Smith & Nephew is recalling a specific knee implant (Legion L-Wedge Size 4) because it contains 5mm screws instead of the required 10mm screws. This error could lead to improper joint fixation during surgery, potentially causing complications. Read more at govinfonow.com/recall/73022-smith-nephew-legion-l-wedge-5mm-screws-instead-of-10mm.
Source Summary by GovInfoNow · govinfonow.com/recall/73022-smith-nephew-legion-l-wedge-5mm-screws-instead-of-10mm · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0092-2018
Cite this page
“Smith & Nephew Legion L-Wedge: 5mm screws instead of 10mm.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/73022-smith-nephew-legion-l-wedge-5mm-screws-instead-of-10mm. Based on FDA recall #Z-0092-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0092-2018%22&limit=1).
Why it’s dangerous
The implant uses 5mm screws instead of the required 10mm screws. This mismatch means the implant may not fix properly to the bone during surgery, potentially causing joint instability or improper healing.
Who’s affected
Patients who received this specific knee implant during revision surgery are affected. Surgeons using this model for procedures on patients with absent or incompetent ligaments are most at risk.
How to tell if you have this one
Check for the product name 'Legion L-Wedge Size 4' with reference number 71421733. The implant was sold with lot number 14GSM0440A.
- Brand
Smith & Nephew- Category
Medical device
What to do — step by step
Check Product Details
Look for the reference number 71421733 and lot number 14GSM0440A on the implant packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.9 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-0092-2018 (September 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0092-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 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.