Hamburg, Germany
Waldemar Link GmbH & Co. KG (Corp. Hq.) recalls
1 recall recorded since 2018, most recently on 11 September 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 11 September 2024
- 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.
- Distribution
- US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3245-2024
- LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.