Recall Z-1418-2022— Smith & Nephew, Inc.

Name: FDA recall Z-1418-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-27

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2022-06-27, terminated 2026-03-25. It names one FDA 510(k) clearance: K951987. Product: (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.. Reason: The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-06-27
Terminated: 2026-03-25
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

(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.

Reason for recall

The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

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