Recall Z-1510-2020— Arthrex, Inc.

Name: FDA recall Z-1510-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-01

Class II · Terminated

Class II FDA medical device recall by Arthrex, Inc., initiated 2019-10-01, terminated 2021-09-08. It names one FDA 510(k) clearance: K141735. Product: Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.. Reason: Screws provided in the device package are 6 mm longer than intended..

Recalling firm: Arthrex, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-10-01
Terminated: 2021-09-08
Firm location: Naples, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K141735 — ARTHREX ANKLE FUSION PLATING SYSTEMArthrex, Inc.·cleared 2014-08-15

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

Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.

Reason for recall

Screws provided in the device package are 6 mm longer than intended.

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