Recall Z-2883-2018— Smith & Nephew, Inc.

Name: FDA recall Z-2883-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-01

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2017-08-01, terminated 2019-02-19. It names one FDA 510(k) clearance: K951987. Product: GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis. Reason: Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-08-01
Terminated: 2019-02-19
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K951987 — GENESIS II TOTAL KNEE SYSTEMSmith & Nephew Richards, Inc.·cleared 1995-08-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis

Reason for recall

Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.

Data sourced from openFDA. This site is unofficial and independent of the FDA.