Waldemar Link GmbH & Co. KG (Corp. Hq.): LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

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.

Details from the source

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. Quantity: 32 devices Lot/code info: UDI-DI: 04026575215539; Lot Codes: C204156; C219063; C219064; C233033; C233034; C332135

UPC codes

04026575215539

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.