LEGION — Class II medical device recall Z-2092-2016
Terminated recall by Smith & Nephew, Inc., reported 2016-07-06, distributed nationwide. The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
| Recall number | Z-2092-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2016-05-26 |
| Classified | 2016-06-29 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2019-08-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, DE, FR, GB, IT, NL, SE, ZA |
| Quantity | 33 units |
| Lot numbers | 15KM09161, 15KM09163, 15KM09175, 15KM09183, 15KM17714, 15KM17800, 15KM17806, 15KM17809, 15KM17817, 15LM01258, 15LM01259, 15LM01260, 15LM01261, 15LM08803, 15LM08816, 15LM08820, 15LM08821, 71421375 |
| Model numbers | 71421374 |
Product
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 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.
Reason for recall
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2092-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.