DePuy Mitek, Inc., a Johnson & Johnson Co.: COR Disposable Kit, 8 mm. Cartilage Transplant System.

Hazard

Device is missing the pin in the graft loader component.

Details from the source

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. Quantity: US: 131 units; OUS: 312 units 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.

UPC codes

10886705012374, 10886705012404

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.