Summary
The FDA issued a Class II for Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615 by Corin Ltd. Reason: The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa..
Details
Source
Device Recall
External ID
Z-0727-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
Product Description
Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
Lot/Code Info: UDI/DI (01) 0 5055196 96834, Lot 503151
Quantity Affected: 12 units
Reason for Recall
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
Distribution
US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-08
Company
Cirencester
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 404 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-0727-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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