Recall Z-2945-2020— Smith & Nephew, Inc.

Name: FDA recall Z-2945-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-24

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-08-24, terminated 2022-07-11. It names one FDA 510(k) clearance: K140814. Product: EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.. Reason: Multiple or incorrect expiration dates were provided on the affected designation labels..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-08-24
Terminated: 2022-07-11
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K140814 — EVOS MINI-FRAGMENT PLATING SYSTEMSmith & Nephew, Inc.·cleared 2014-05-07

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

EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.

Reason for recall

Multiple or incorrect expiration dates were provided on the affected designation labels.

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