DePuy Mitek, Inc., A Johnson & Johnson Co. recalls COR Disposable Kit
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. 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 detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1314-2025
- FDA device classification · LXHOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.4540The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find DePuy Mitek, Inc., a Johnson & Johnson Co.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
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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