Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated
Summary
The FDA issued a Class II for Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-898 by Arthrex, Inc.. Reason: The devices may be packaged with the wrong reamer size..
Details
Source
Device Recall
External ID
Z-0465-2023
Action Date
2022-12-14
Status
Ongoing
Category
device
Product Description
Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.
Lot/Code Info: AR-8981-06S, batch 2003118198, UDI/DI 00888867056817; and AR-8981-08S, batch 2014118685, UDI/DI 00888867056824.
Quantity Affected: 123 pieces
Reason for Recall
The devices may be packaged with the wrong reamer size.
Distribution
Distribution was made to AL, AR, CA, CO, FL, IA, IL, LA, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, UT, and VA. There was no military/government distribution. Foreign distribution was made to Ecuador, Germany, Russia, Canada, China, Finland, France, Germany, Portugal, and the United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-02
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 176 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-0465-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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