Stryker Leibinger GmbH & Co. KG recalls MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

Recall date

December 29, 2021

Source

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

Recall number

Z-0715-2022

FDA classification

Class II

Brand / firm

Stryker Leibinger GmbH & Co. KG

Sold / distributed

Worldwide distribution - US Nationwide.

Why it was recalled

Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.

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

What was recalled

MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032