Recall Z-2444-2023— Smith & Nephew, Inc.

Name: FDA recall Z-2444-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-24

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2023-07-24. It names 2 FDA 510(k) clearances: K210980, K040462. Product: TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail. Reason: A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-07-24
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

2 on FDA's record

K210980 — Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc.·cleared 2022-11-14
K040462 — TRIGEN TROCHANTERIC ANTEGRADE NAILSmith & Nephew, Inc.·cleared 2004-03-23

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

TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail

Reason for recall

A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.

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