FDA recall Z-3245-2024

Waldemar Link GmbH & Co. KG (Corp. Hq.) · Class II · device

Product

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

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.

Key facts

Status: Ongoing
Initiation date: 2024-09-11
Report date: 2024-10-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hamburg, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3245-2024