COR Disposable Cartilage Transplant Kit recalled for missing graft loader pin
DePuy Mitek's COR Disposable Cartilage Transplant System is being recalled because some units are missing a pin in the graft loader component, which could affect surgical function.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involving a manufacturing defect in a surgical implant system. The missing pin component in the graft loader could prevent proper device function during surgical procedures. No illnesses or injuries have been reported, but the defect affects a risk-of-harm product.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson subsidiary, is recalling the COR Disposable Kit (8 mm) Cartilage Transplant System. The recalled units are missing the pin component in the graft loader, which is essential for proper device function during surgical procedures.
The recall affects 131 units distributed nationwide in the United States and 312 units distributed internationally across 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 lot numbers are 23C11, 23C12, 23E04, 23F02, 23R03, 24A02, 24B01, 24C17, 24P07, 23C13, 23D03, 23D14, 23F01, 24C15, 24K07, and 24N10.
Healthcare providers and patients who have received this device should contact DePuy Mitek immediately. Do not use affected units. Contact your healthcare provider if you have questions about whether you received an affected device or if you have experienced any problems related to this device.
The recalled product
- Product
- COR Disposable Kit, 8 mm. Cartilage Transplant System.
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
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.
Part of a larger recall action
This product is one of 2 recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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