FDA Device recall Z-1315-2025
COR Disposable Kit, 8 mm w/ Perpendicularity
- FDA Device
- Class II
- ongoing
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class II recall of COR Disposable Kit, 8 mm w/ Perpendicularity by Depuy Mitek A Johnson And Johnson, citing device is missing the pin in the graft loader component.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1315-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-24 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Depuy Mitek A Johnson And Johnson |
| Distribution | US |
Product
COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Reason
Device is missing the pin in the graft loader component.
Identifiers
| code_info | Model No. 252109 & 252112; GTIN: 10886705012374 & 10886705012404; Lot No. 23C11, 23C12, 23E04, 23F02, 23R03, 24A02, 24B…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1315-2025%22
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