Waldemar Link GmbH & Co. KG (Corp. Hq.) recalls LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

Recall date

September 11, 2024

Source

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

Recall number

Z-3245-2024

FDA classification

Class II

Brand / firm

Waldemar Link GmbH & Co. KG (Corp. Hq.)

Sold / distributed

US Nationwide distribution in the states of FL, KS, MI, NJ, VA.

Why it was recalled

Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.

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

What was recalled

LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01