Recall Z-0408-2018— Smith & Nephew, Inc.

Name: FDA recall Z-0408-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-29

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2017-11-29, terminated 2020-09-01. It names one FDA 510(k) clearance: K140814. Product: smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.. Reason: One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-11-29
Terminated: 2020-09-01
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

smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.

Reason for recall

One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.

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