Reported Oct 10, 2018 · Ongoing
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114,…
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
- JOURNEY BCS OXINIUM Knee Femoral Components
- Catalog Numbers
74021110740211117402111274021113740211147402111574021116740211177402111874021119740211207402112174021122740211237402112474021125740211267402112774021128740211297402113074021131740211327402113374021134740211357402113674021137740211387402113974021140740211417402114274021143740211447402114574021146740211477402114874021149
- Lot codes and dates
- All lots
- Amount recalled
- 42,050 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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