Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
Summary
The FDA issued a Class II for Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENT by Corin Ltd. Reason: One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630..
Details
Source
Device Recall
External ID
Z-1509-2022
Action Date
2022-08-17
Status
Ongoing
Category
device
Product Description
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
Lot/Code Info: UDI (01) 0 505563 89123 0 (10) 485630 (17) 261114, Lot Number 485630
Quantity Affected: 5 devices
Reason for Recall
One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
Distribution
US Nationwide distribution in the states of OK, TX, FL.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-22
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 96 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-1509-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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