CORIN MEDICAL, LTD. recalls Apex Knee System. Model Numbers: KC-50090

Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.

Corin Group notified US agents informally via email on 05/23/2025 and informed them of an investigation and affected inventory to quarantine. A formal notification was sent to consignees on about 06/02/2025. Consignees were instructed to identify any affected units on hand and quarantine them, return them to Corin and notify all affected parties who handled the product. Consignees were also requested to complete and return the acknowledgement form. If product was further distributed, Corin requested contact information to contact those customers.

• FDA enforcement recordOfficial FDA database entry for Z-2069-2025
• FDA 510(k) clearance · K101994The device's official FDA premarket clearance record
• FDA 510(k) clearance · K112891The device's official FDA premarket clearance record
• FDA 510(k) clearance · K153437The device's official FDA premarket clearance record
• FDA device classification · JWHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3560The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CORIN MEDICAL, LTD.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.