Recall Z-0158-2024 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
| Date | Oct 24, 2023 (initiated Sep 27, 2023) |
| Status | Open, Classified |
| Reason | The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM. |
| Root cause | Component change control |
| Action | Smith & Nephew, Inc. issued an Urgent Medical Device Recall Notice to its consignees on 09/27/2023 via email and overnight mail. The notice explain the issue, potential risk, and requested the following actions: Inspect inventory, locate, and quarantine the affected devices. Sales representatives, district offices, or distributors were directed to notify their customers The firm is seeking return of unused products. |
| Quantity | 29 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Japan. |
| FDA record | Open on fda.gov |