COR Disposable Kit, 8 mm. Cartilage Transplant System.
Summary
The FDA issued a Class II for COR Disposable Kit, 8 mm. Cartilage Transplant System. by DePuy Mitek, Inc., a Johnson & Johnson Co.. Reason: Device is missing the pin in the graft loader component..
Details
Source
Device Recall
External ID
Z-1314-2025
Action Date
2025-03-19
Status
Ongoing
Category
device
Product Description
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Lot/Code Info: Model No. 252109 & 252112; GTIN: 10886705012374 & 10886705012404; Lot No. 23C11, 23C12, 23E04, 23F02, 23R03, 24A02, 24B01, 24C17, 24P07, 23C13, 23D03, 23D14, 23F01, 24C15, 24K07 & 24N10.
Quantity Affected: US: 131 units; OUS: 312 units
Reason for Recall
Device is missing the pin in the graft loader component.
Distribution
Domestic: Nationwide Distribution; Foreign: Austria, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Spain, Finland, France, French Guyana, Greece, Israel, India, Italy, Japan, South Korea, Luxemburg, Mexico, Netherlands, Poland, Portugal & Singapore.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-24
Company
Norwood, MA
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 159 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DePuy Mitek, Inc., a Johnson & Johnson Co. has 7 FDA actions in our database, including 7 recalls.
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 (DePuy Mitek, Inc., a Johnson & Johnson Co.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DePuy Mitek, Inc., a Johnson & Johnson Co. have FDA actions?
DePuy Mitek, Inc., a Johnson & Johnson Co. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1314-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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