Recall Z-1360-2016— Arthrex, Inc.

Name: FDA recall Z-1360-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-11

Class II · Terminated

Class II FDA medical device recall by Arthrex, Inc., initiated 2016-01-11, terminated 2019-07-24. It names one FDA 510(k) clearance: K031666. Product: Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.. Reason: Potential for a component contained in the Implant System to be non-sterile..

Recalling firm: Arthrex, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-11
Terminated: 2019-07-24
Firm location: Naples, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K031666 — ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DSArthrex, Inc.·cleared 2003-11-18

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

Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.

Reason for recall

Potential for a component contained in the Implant System to be non-sterile.

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