Z-3245-2024 Class II Ongoing
FDA device recall Z-3245-2024 was initiated by Waldemar Link GmbH & Co. KG (Corp. Hq.) on September 11, 2024 and is designated Class II. 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 ins… The recall status is ongoing. Affected quantity: 32 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2024
- Initiation Date
- September 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 devices
Product Description
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 Pattern
US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
Code Information
UDI-DI: 04026575215539; Lot Codes: C204156; C219063; C219064; C233033; C233034; C332135