Recall Z-0281-2025— Smith & Nephew Inc

Name: FDA recall Z-0281-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-02

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew Inc, initiated 2024-10-02. It names one FDA 510(k) clearance: K962557. Product: smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic. Reason: Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label..

Recalling firm: Smith & Nephew Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-10-02
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K962557 — GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTSmith & Nephew Richards, Inc.·cleared 1996-12-05

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

smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic

Reason for recall

Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.

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