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FDA-Device2018-10-10Class IIPROCESSING DEFECT

Smith & Nephew JOURNEY BCS OXINIUM Knee Femoral Components recalled for higher-than-expected revision rates

Smith & Nephew
OTHERNationwide distribution

Contact your doctor about JOURNEY BCS knee implant

Smith & Nephew's JOURNEY BCS OXINIUM knee implants have a revision rate (need for replacement surgery) that is over 1.5 times higher than the average for similar knee replacement devices, according to joint replacement registries in England, Wales, Northern Ireland, and Australia. This means patients with these implants may be more likely to need additional surgery.

  • If you received a JOURNEY BCS OXINIUM knee implant, contact your surgeon or orthopedic doctor to discuss your individual situation
  • Ask your doctor whether monitoring or follow-up imaging is recommended
  • Do not stop or delay any prescribed care; your doctor can help determine the best course of action for you
Hazard

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.

Sold states
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.
Affected count
42,050 units
Manufactured in
1450 E Brooks Rd, Memphis, TN, United States
Products
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2019

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