LEGION — Class II medical device recall Z-0591-2015
Terminated recall by Smith & Nephew, Inc., reported 2014-12-17, distributed nationwide. The stem taper on this device is undersized; the gauge point is not deep enough.
| Recall number | Z-0591-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2014-11-04 |
| Classified | 2014-12-11 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2019-08-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CH, CO, DE, KR, SG, TH, ZA |
| Quantity | 23 units |
| Lot numbers | 14EM23391 |
| Model numbers | 71426006 |
Product
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Reason for recall
The stem taper on this device is undersized; the gauge point is not deep enough.
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-0591-2015. 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.