Arthrex Deltoid Ligament Reconstruction Implant System recalled over sterility concerns

Recall date

January 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Arthrex, Inc. recalls Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distr…

Recall number

Z-1360-2016

FDA classification

Class II

Brand / firm

Arthrex, Inc.

Sold / distributed

Distributed to the states of AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, and WI.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.