Waldemar Link GmbH & Co. KG (Corp. Hq.): Device Recall
Recall #Z-3245-2024 · 09/11/2024
Class II: Risk
Recall Details
- Recall Number
- Z-3245-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Status
- Ongoing
- Date Initiated
- 09/11/2024
- Location
- Hamburg, Germany
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 devices
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.
Product Description
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Distribution Pattern
US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.