Cartilage Transplant System Disposable Kits Recalled for Missing Component
DePuy Mitek is recalling COR Disposable Kit cartilage transplant systems because some units lack the pin in the graft loader component. The manufacturing defect may prevent proper device function during surgical use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. The missing critical component in a surgical device represents a manufacturing defect that creates a risk of harm if the device is used during a procedure, meeting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Company, is recalling COR Disposable Kit, 8 mm w/ Perpendicularity cartilage transplant systems due to a manufacturing defect. Affected units are missing the pin in the graft loader component, a part essential for proper operation during cartilage transplant procedures.
The recall affects 131 units distributed nationwide in the United States and 312 units distributed internationally to 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, and Singapore. The affected products are Model Nos. 252109 and 252112 with lot numbers 23C11, 23C12, 23E04, 23F02, 23R03, 24A02, 24B01, 24C17, 24P07, 23C13, 23D03, 23D14, 23F01, 24C15, 24K07, and 24N10.
Healthcare facilities and patients who have received these kits should not use devices if the pin in the graft loader component is missing or damaged. Contact DePuy Mitek or the FDA for guidance on inspecting affected units and arranging replacement or return. Verify the condition of any of these cartilage transplant kits before use.
The recalled product
- Product
- COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- manufacturing-defect
- missing-component
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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.
Distribution
Distributed nationwide across the United States.
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