Recall Z-0772-2021— Smith & Nephew, Inc.

Name: FDA recall Z-0772-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-02

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-11-02, terminated 2023-01-06. It names one FDA 510(k) clearance: K040212. Product: Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;. Reason: Manufacturing packaging error..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-11-02
Terminated: 2023-01-06
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K040212 — TRIGEN INTERTANSmith & Nephew, Inc.·cleared 2004-02-20

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

Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;

Reason for recall

Manufacturing packaging error.

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