Recall Z-2733-2020— Arthrex, Inc.

Name: FDA recall Z-2733-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-24

Class II · Terminated

Class II FDA medical device recall by Arthrex, Inc., initiated 2020-06-24, terminated 2021-02-16. It names one FDA 510(k) clearance: K141478. Product: Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.. Reason: Screws provided in packaging are 5mm shorter than intended.

Recalling firm: Arthrex, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-06-24
Terminated: 2021-02-16
Firm location: Naples, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K141478 — ARTHREX FRACTURE PLATES AND SCREWSArthrex, Inc.·cleared 2014-07-08

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

Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.

Reason for recall

Screws provided in packaging are 5mm shorter than intended

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