Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, d
Summary
The FDA issued a Class II for Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321. by Corin Ltd. Reason: The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination o.
Details
Source
Device Recall
External ID
Z-2604-2021
Action Date
2021-10-06
Status
Terminated
Category
device
Product Description
Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are components of the Trinity Acetabular System.
Lot/Code Info: The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 321.035 - Lot number 481070 was delivered 7/23/2021 and 7/26/2021; and Model 321.050 - Lot number 478892 was delivered 7/23/2021.
Quantity Affected: 6 units
Reason for Recall
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Distribution
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-28
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 201 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-2604-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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