FDASeptember 11, 2024device
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
waldemar link gmbh co kg corp hqwaldemarwaldemar link
UPCs
04026575215539
Recall history
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