LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Reported: October 2, 2024 Initiated: September 11, 2024 #Z-3245-2024
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.
Details
- Recalling Firm
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Units Affected
- 32 devices
- Distribution
- US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
- Location
- Hamburg
Frequently Asked Questions
What product was recalled? ▼
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01. Recalled by Waldemar Link GmbH & Co. KG (Corp. Hq.). Units affected: 32 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2024. Severity: Moderate. Recall number: Z-3245-2024.
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