FDA Enforcement
Class II
Ongoing
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
Recall: Z-0158-2024
·
Reported November 1, 2023
Enforcement
- Recall Number
- Z-0158-2024
- Event ID
- 93156
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Smith & Nephew, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- November 1, 2023
- Initiation Date
- September 27, 2023
- Classification Date
- October 24, 2023
- Address
- 1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States
Description
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
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.
Code Info
UDI/DI 00885556176467, Batch Number 22BM17564
Distribution
Worldwide distribution - US Nationwide and the country of Japan.
Quantity
29 units