CLASS II Device recall · Reported 6 Jul 2016 · FDA Enforcement Report
Legion(tm) Hk Femoral Assembly, Size 4 Right, A/p, M/l recalled
Smith & Nephew is recalling Legion(tm) Hk Femoral Assembly, Size 4 Right, A/p, M/l, distributed nationwide in the US. The recall was initiated on 26 May 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2093-2016
- FDA event ID
- 74271
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 May 2016
- FDA classified
- 29 Jun 2016
- Reported
- 6 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 26 May 2016 | Recall initiated by company | |
| 29 Jun 2016 | Classified by FDA | +34 days |
| 6 Jul 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
Product as listed by the FDA
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee System is indicated for: 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.
Where it was distributed
Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.
Stores named: Walmart
Questions about this recall
Is Legion(tm) Hk Femoral Assembly, Size 4 Right, A/p, M/l recalled?
Yes. Smith & Nephew recalled Legion(tm) Hk Femoral Assembly, Size 4 Right, A/p, M/l on 26 May 2016. The recall is Class II and its status is Terminated. Recall number Z-2093-2016.
Why was it recalled?
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
Which lots are affected?
Lot codes: 15KM20807,15KM20808,15KM20811,15KM20812,15LM08258,15LM12482,15MM03005,15MM03007
Where was it sold?
Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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