Recall Z-3245-2024— Waldemar Link GmbH & Co. KG (Corp. Hq.)
Class II · Ongoing
Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Corp. Hq.), initiated 2024-09-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-11
- Firm location
- Hamburg, Germany
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.