Drug recall
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
FDA recall event 95344 · Class II · Waldemar Link GmbH & Co. KG (Corp. Hq.)
Key facts
| Event ID | 95344 |
|---|---|
| Recall numbers | Z-3245-2024 |
| Recalling firm | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Product type | Devices |
| Products | LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 11, 2024 |
| Report date | Oct 2, 2024 |
| City | Hamburg |
| Country | Germany |
| FEI number | 3002808472 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: