—#88035

Product

JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 49 MM, M/L 29 MM, REF 71422224, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116

FDA product code: HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K052265
Affected lot / code info: All Lot Numbers

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew Inc
Address: 1450 E. Brooks Rd, Memphis, Tennessee 38116

Distribution

Distribution pattern: US and Argentina, Switzerland, Australia, Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany, Malaysia, Portugal, Netherlands, Singapore, and England

Timeline

Recall initiated: 2009-01-23
Posted by FDA: 2010-03-03
Terminated: 2011-03-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88035. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.