Summary
The FDA issued a Class II for Unity Total Knee System. Used for knee prosthesis in total knee replacement by Corin Ltd. Reason: The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packagi.
Details
Source
Device Recall
External ID
Z-0273-2023
Action Date
2022-11-30
Status
Terminated
Category
device
Product Description
Unity Total Knee System. Used for knee prosthesis in total knee replacement
Lot/Code Info: Model Number: 112.040.06; Lot Number: 504337
Quantity Affected: 4 devices
Reason for Recall
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
Distribution
Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-31
Company
Cirencester, N/A
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 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Corin Ltd has 18 FDA actions in our database, including 17 recalls and 1 clearance.
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 (Corin Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Corin Ltd have FDA actions?
Corin Ltd has 18 FDA actions in our database, including 17 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0273-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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