FDAFDA · Food and drugs·Recall number Z-3245-2024
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Published October 2, 2024 · Recall initiated: September 11, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Distributor
- US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
- Lot
- UDI-DI: 04026575215539; Lot Codes: C204156; C219063; C219064; C233033; C233034; C332135
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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