Z-0158-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2023
- Initiation Date
- September 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 units
Product Description
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Japan.
Code Information
UDI/DI 00885556176467, Batch Number 22BM17564