COR Disposable Kit recall
COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Why was COR Disposable Kit recalled?
Device is missing the pin in the graft loader component.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Quantity
- US: 131 units; OUS: 312 units
- 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.
- Recall date
- March 19, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)