Z-0948-2010

Journey " Uni Tibial Insert Right Medial/ Left Lateral, A/p 46 Mm, M/l 27 Mm, Ref 71422257, Qty: (1), Sterile...

Name: Z-0948-2010 Journey " Uni Tibial Insert Right Medial/ Left Lateral, A/p 46 Mm, M/l 27 Mm, Ref 71422257, Qty: (1), Sterile...
Creator: Smith & Nephew Inc
Published: 2009-01-23
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2009-01-23 / Terminated / root cause: design

FDA source

Smith & Nephew Inc began a recall of JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422257, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 on 2009-01-23. The reason FDA records is "The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0948-2010
Status: Terminated
Initiated: 2009-01-23
Posted: 2010-03-03
Terminated: 2011-03-25
Recalling firm: Smith & Nephew, Inc.
Product: Journey " Uni Tibial Insert Right Medial/ Left Lateral, A/p 46 Mm, M/l 27 Mm, Ref 71422257, Qty: (1), Sterile Eo, Smith & Nephew, Inc. Memphis, Tn 38116
Product code: HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Reason for recall: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct.
Root cause tag: design
FDA root cause: Device Design
Action: All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on 12/23/2009. All affected Smith & Nephew International Distributors were notified via e-mail and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return. For questions, please contact the firm, Leah Easley at 901-399-6137.
Quantity in commerce: 952 units
Distribution: US and Argentina, Switzerland, Australia, Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany, Malaysia, Portugal, Netherlands, Singapore, and England
Product codes and lots: All Lot Numbers

Product code HSX

K052265Class IISmith & Nephew Competitor Duo Knee FemoralSmith & Nephew, Inc. / cleared 2005-12-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)