LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Summary
The FDA issued a Class II for LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Numb by Waldemar Link GmbH & Co. KG (Corp. Hq.). Reason: Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when .
Details
Source
Device Recall
External ID
Z-3245-2024
Action Date
2024-10-02
Status
Ongoing
Category
device
Product Description
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Lot/Code Info: UDI-DI: 04026575215539; Lot Codes: C204156; C219063; C219064; C233033; C233034; C332135
Quantity Affected: 32 devices
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.
Distribution
US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-11
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Waldemar Link GmbH & Co. KG (Corp. Hq.)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Waldemar Link GmbH & Co. KG (Corp. Hq.) have FDA actions?
This is the only FDA action we have on record for Waldemar Link GmbH & Co. KG (Corp. Hq.) in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3245-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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