Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
Summary
The FDA issued a Class II for Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A by New Standard Device Inc. Reason: Due to manufacturing processing error, wrench causing stripping when torqueing nuts..
Details
Source
Device Recall
External ID
Z-1280-2022
Action Date
2022-06-29
Status
Ongoing
Category
device
Product Description
Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
Lot/Code Info: Catalog/Part Number: 900104 UDI-DI (GTIN): 854641008112 Lot Number: A29618A
Quantity Affected: 14 devices
Reason for Recall
Due to manufacturing processing error, wrench causing stripping when torqueing nuts.
Distribution
U.S.: AZ. CT, GA, OH, and VA O.U.S.: N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2019-08-14
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 107 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-1280-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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