FDA Device recall Z-0590-2015
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic by Smith And Nephew, citing the stem taper on this device is undersized; the gauge point is not deep enough.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0590-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-04 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Reason
The stem taper on this device is undersized; the gauge point is not deep enough.
Identifiers
| code_info | Lot Numbers: 14EM16708, 14EM21988, 14DM22269 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0590-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.