Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Summary
The FDA issued a Class II for Unity Total Knee System, Model Number 112.001.34. Primary and revision tota by Corin Ltd. Reason: Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa v.
Details
Source
Device Recall
External ID
Z-0214-2024
Action Date
2023-11-08
Status
Ongoing
Category
device
Product Description
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Lot/Code Info: UDI/DI 05055343872505, Lot Number 532405.
Quantity Affected: 1 units
Reason for Recall
Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
Distribution
US: MI, TX, IL
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-13
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 156 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-0214-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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