Z-0001-2019 Class II Ongoing
FDA device recall Z-0001-2019 was initiated by Smith & Nephew, Inc. on Jun 13, 2018 and is designated Class II. Reason for recall: The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first… The recall status is ongoing. Affected quantity: 10,792 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 10, 2018
- Initiation Date
- Jun 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,792 units
Product Description
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Reason for Recall
The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.
Distribution Pattern
Worldwide distribution, including US nationwide and Puerto Rico, Austria, United Arab Emirates, Australia, Belgium, Canada, China, Switzerland, Germany, Denmark, Finland, France, Great Britain, India, Spain, Italy, Netherlands, Portugal, Sweden, Venezuela, South Africa.
Code Information
All lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0001-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026