Z-0002-2019Class II

JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113...

Name: Z-0002-2019 JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113...
Creator: Smith & Nephew, Inc.
Published: 2018-06-13
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2018-06-13 / Open, Classified

FDA source

Smith & Nephew, Inc. began a recall of JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118... on 2018-06-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0002-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-06-13
Posted: 2018-10-01
Recalling firm: Smith & Nephew, Inc.
Product: 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 code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
FDA root cause: Other
Action: The Field Safety Notice (FSN) sent to risk managers on 06/13/2018 asks customers to inspect inventory, locate and quarantine affected, unused Journey BCS Knee CoCr Femoral Components and JOURNEY BCS OXINIUM Knee Femoral Components. Affected product subject of the voluntary removal is to be returned to Smith & Nephew. All consignees are asked to complete an FSN Response Form, even if they do not have product to return. The Field Safety Notice, communicated with surgeons that these first generation JOURNEY BCS tibial inserts should only be used for polyethylene exchange revision of the first generation JOURNEY BCS total knee constructs where the femoral component and tibial baseplate are well-fixed. This notification, addressed to implanting surgeons, requesting their receipt and acknowledgement of the FSN.
Quantity in commerce: 42,050 units
Distribution: 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.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0002-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0001-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-0002-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-0003-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-10-10	2018-10-01

Product code JWH

K042515Class IISmith & Nephew, Inc. High Performance KneeSmith & Nephew, Inc. / cleared 2005-03-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)