Class II

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

Waldemar Link GmbH & Co. KG (Corp. Hq.) · September 11, 2024

Reason for Recall

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.

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

32 devices

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3245-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.