Smith & Nephew, Inc. recalls LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee…
- Recall date
- January 15, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2538-2019
- FDA classification
- Class II
- Brand / firm
- Smith & Nephew, Inc.
- Sold / distributed
- Foreign countries of; France, Germany, Netherlands, Norway, Switzerland
Why it was recalled
The affected products were inadvertently packaged with an incorrect screw component.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.
Get recall alerts
Free email alert whenever Smith & Nephew, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Smith & Nephew, Inc.