Smith & Nephew, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0002-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 13, 2018

Date Posted: October 10, 2018

Recall Number: Z-0002-2019

Event ID: 80313

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.

Status: Ongoing

Product Quantity: 42,050 units

Code Information:

All lots

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.

Voluntary or Mandated:

Voluntary: Firm initiated