Summary
The FDA issued a Class II for K-Wire, 1.35 mm x 170 mm by Arthrex, Inc.. Reason: Products do not meet length and diameter specifications..
Details
Source
Device Recall
External ID
Z-1035-2022
Action Date
2022-05-11
Status
Terminated
Category
device
Product Description
K-Wire, 1.35 mm x 170 mm
Lot/Code Info: Part Number: AR-8610K-43, Batch 1298116640 UDI: 00888867197084
Quantity Affected: 300 pieces
Reason for Recall
Products do not meet length and diameter specifications.
Distribution
Worldwide distribution - US Nationwide distribution in the states of OH, TN, MO, LA, IA, AZ, PA, NY, OR and the countries of to Belgium, Egypt, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, and Spain.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-25
Company
Naples, FL
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 121 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Arthrex, Inc. has 80 FDA actions in our database, including 3 recalls and 77 clearances.
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 (Arthrex, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Arthrex, Inc. have FDA actions?
Arthrex, Inc. has 80 FDA actions in our database, including 3 recalls and 77 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1035-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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