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RecallWatchMedical Device Safety
Class IIOngoingZ-1315-2025

DePuy Mitek, Inc., A Johnson & Johnson Co. recalls COR Disposable Kit

DePuy Mitek, Inc., a Johnson & Johnson Co.Norwood, MA, United StatesReported Mar 19, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Device is missing the pin in the graft loader component.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.

Lot / code information

Model
252109 & 252112
GTIN
10886705012374 & 10886705012404
Lot #
23C11, 23C12, 23E04, 23F02, 23R03, 24A02, 24B01, 24C17, 24P07, 23C13, 23D03, 23D14, 23F01, 24C15, 24K07 & 24N10

What the firm is doing

Consignees were sent an URGENT MEDICAL DEVICE RECALL (REMOVAL) notification dated 2/20/25. The notification instructs consignees to examine their inventory and quarantine any affected devices. Recalled product is not to be used. Once affected devices have been quarantined, consignees are to contact their DePuy Synthes Sales Consultant to coordinate their return. Consignees are to complete and return the provided Business Response Form to the provided email address within three business days of receipt. The recall notification should be shared with those in your organization that need to be informed and forwarded to facilities to which product was further distributed. The recall notification should also be posted in a visible area for awareness. Consignees with any questions are to contact their DePuy Synthes Sales Consultant.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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