DePuy Spine, Inc. recalls EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an…

Recall date

May 20, 2022

Source

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

Recall number

Z-1323-2022

FDA classification

Class II

Brand / firm

DePuy Spine, Inc.

Sold / distributed

Distribution US Nationwide

Why it was recalled

Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton

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

What was recalled

EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD). Part Number: CUI8060L