Reported Oct 10, 2018 · Ongoing
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116,…
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
- Knee Conventional Polyethylene Inserts
194 of 194 codes
740231117402311274023113740231147402311574023116740231177402311874023121740231227402312374023124740231257402312674023127740231287402313174023132740231337402313474023135740231367402313774023138740231417402314274023143740231447402314574023146740231477402314874023211740232127402321374023214740232157402321674023217740232187402322174023222740232237402322474023225740232267402322774023228740232317402323274023233740232347402323574023236740232377402323874023241740232427402324374023244
- Lot codes and dates
- All lots
- Amount recalled
- 64642
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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