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Waldemar Link GmbH & Co. KG (Corp. Hq.) recalls LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Recalled October 2, 2024 · FDA recall Z-3245-2024 · Waldemar Link GmbH & Co. KG (Corp. Hq.)
Hazard
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. · FDA Class II
Units
32 devices
Sold at
US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
Description
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.
Product
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Manufacturer(s)
Waldemar Link GmbH & Co. KG (Corp. Hq.)
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →