Reported Jul 6, 2016 · Terminated
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is…
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | Rheumatoid arthritis. |
| 2 | Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. |
| 3 | Failed osteotomies, unicompartmental replacement, or total knee replacement. |
| 4 | Posterior stabilized knee systems are designed for use in patients in primary and revision surgery |
| 5 | Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only. |
- Lot codes and dates
- Lot codes
15JM0456115JM0457015JM0458915KM0893615KM0893715KM0894015KM0894215KM0894815KM0894915KM0901015KM0901115KM0901315KM0901415KM0901515KM0901615LM0911915LM0912215LM0912315LM0912415LM1248315LM1248415LM1248615LM1248815LM1565215MM0982915MM0983316AM1222216AM1222416AM1223516AM1223716AM1224016AM1224316AM1225516AM12268
- Lot codes
- Amount recalled
- 97 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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