APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Summary
The FDA issued a Class II for APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with by Medartis Inc.. Reason: Screw is 16mm long instead of 22mm long..
Details
Source
Device Recall
External ID
Z-1821-2024
Action Date
2024-05-22
Status
Ongoing
Category
device
Product Description
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Lot/Code Info: Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.
Quantity Affected: 110 units
Reason for Recall
Screw is 16mm long instead of 22mm long.
Distribution
Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-12
Company
Warsaw, IN
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 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medartis Inc. has 2 FDA actions in our database, including 1 recall and 1 clearance.
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 (Medartis Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medartis Inc. have FDA actions?
Medartis Inc. has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1821-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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