1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Summary
The FDA issued a Class II for 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plat by New Standard Device Inc. Reason: 1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are.
Details
Source
Device Recall
External ID
Z-1236-2022
Action Date
2022-06-15
Status
Completed
Category
device
Product Description
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Lot/Code Info: UDI: 854641008419, Lots: A29518X and A17219DA
Quantity Affected: 426
Reason for Recall
1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.
Distribution
US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.
Type: Voluntary: Firm initiated
Recall Initiated: 2020-06-08
Company
San Antonio, TX
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 178 device recalls issued in the same week, part of 403 device-related FDA actions this month.
New Standard Device Inc has 4 FDA actions in our database, including 4 recalls.
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 (New Standard Device Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does New Standard Device Inc have FDA actions?
New Standard Device Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1236-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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