JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
FDA device recall Z-0157-2024 · posted 2023-10-24 · Open, Classified
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Component change control
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 28 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Japan.
- Date initiated
- 2023-09-27
- Date posted
- 2023-10-24
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JOURNEY II BCS CONSTRAINED INSERTS (K140555) | Smith & Nephew, Inc. | 2014-05-29 |
| JOURNEY II BCS KNEE SYSTEM (K111711) | Smith & Nephew, Inc. | 2011-09-16 |