DePuy Orthopaedics, Inc. recalls DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total sh…

Recall date

August 31, 2017

Source

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

Recall number

Z-0833-2018

FDA classification

Class II

Brand / firm

DePuy Orthopaedics, Inc.

Sold / distributed

Nationally

Why it was recalled

The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.

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

What was recalled

DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.