Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self
Summary
The FDA issued a Class II for Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation S by New Standard Device Inc. Reason: Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery..
Details
Source
Device Recall
External ID
Z-1649-2022
Action Date
2022-09-07
Status
Ongoing
Category
device
Product Description
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
Lot/Code Info: Part Number / DESCRIPTION / UDI-DI Code / Lot Numbers: 620030 / Self-Drill Half-Pin 5x30x215mm / 854641008198 / A29418X, A17219CA 620040 / Self-Drill Half-Pin 5x40x215mm / 854641008204 / A29418Y, A17219CB 620060 / Self-Drill Half-Pin 5x60x215mm / 854641008211 / A29418Z, A17219CC 620080 / Self-Drill Half-Pin 5x80x215mm / 854641008228 / A29518A, A17219CD
Quantity Affected: 410 total devices
Reason for Recall
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Distribution
U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None
Type: Voluntary: Firm initiated
Recall Initiated: 2020-12-28
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 164 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-1649-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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