FDA-Device2024-10-02Class II
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
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.
Sold states
US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
Affected count
32 devices
Manufactured in
Barkhausenweg 10, Hamburg, Germany
Products
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3245-2024Don't want to check this manually?
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