FDA Enforcement
Class II
Ongoing
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Recall: Z-3245-2024
·
Reported October 2, 2024
Enforcement
- Recall Number
- Z-3245-2024
- Event ID
- 95344
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 2, 2024
- Initiation Date
- September 11, 2024
- Classification Date
- September 24, 2024
- Address
- Barkhausenweg 10, Hamburg, N/A, Germany
Description
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Reason
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.
Code Info
UDI-DI: 04026575215539; Lot Codes: C204156; C219063; C219064; C233033; C233034; C332135
Distribution
US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
Quantity
32 devices