JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422255, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116
FDA Recall Z-0946-2010 · Posted 2010-03-03
Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeHSX
Date Initiated2009-01-23
Date Terminated2011-03-25
Product Quantity1907 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
US and Argentina, Switzerland, Australia, Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany, Malaysia, Portugal, Netherlands, Singapore, and England
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.