LINK Universal Handle recall
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Why was LINK Universal Handle 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 04026575215539; Lot Codes: C204156; C219063; C219064; C233033; C233034; C332135
- Product
- LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
- Recalling firm
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Quantity
- 32 devices
- Distribution
- US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
- Recall date
- October 2, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)