Summary
The FDA issued a Class II for 6.5MMX165MM CANNULATED SCREW by Smith & Nephew, Inc.. Reason: The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded..
Details
Source
Device Recall
External ID
Z-0143-2022
Action Date
2021-10-27
Status
Terminated
Category
device
Product Description
6.5MMX165MM CANNULATED SCREW
Lot/Code Info: Model 71106365S; Lot 20GT39417
Quantity Affected: 5 units
Reason for Recall
The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
Distribution
Worldwide distribution - US Nationwide distribution in the states of OK, TN and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-20
Company
Memphis, TN
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 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smith & Nephew, Inc. has 78 FDA actions in our database, including 34 recalls and 44 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 (Smith & Nephew, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smith & Nephew, Inc. have FDA actions?
Smith & Nephew, Inc. has 78 FDA actions in our database, including 34 recalls and 44 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0143-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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