JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
This recall is currently active, issued October 24, 2023. It was issued by Smith & Nephew Inc.
- Company
- Smith & Nephew Inc
- Recall Initiated
- September 27, 2023
- Posted
- October 24, 2023
- Recall Number
- Z-0157-2024
- Quantity
- 28 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
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
Worldwide distribution - US Nationwide and the country of Japan.
Lot / Code Info
UDI/DI 00885556178010, Batch Number 22BM18348
Root Cause
Component change control
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.