'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100
Summary
The FDA issued a Class II for 'n'-Hole Post which is a component of the Revolution External Fixation System by New Standard Device Inc. Reason: The threads on posts stripping out when tensioned during application process..
Details
Source
Device Recall
External ID
Z-1824-2023
Action Date
2023-06-21
Status
Ongoing
Category
device
Product Description
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
Lot/Code Info: Catalog Numbers / Lot Numbers: 100801 / A29318R 100802 / A29318S 100803 / A29318T 100804 / A29318U 100805 / A29318V UDI Codes: Not provided/None
Quantity Affected: 222 units
Reason for Recall
The threads on posts stripping out when tensioned during application process.
Distribution
U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2019-07-23
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 137 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-1824-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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