Recall Z-0944-2010 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Smith & Nephew Inc
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422253, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116
| Date | Mar 3, 2010 (initiated Jan 23, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 813 units |
| Distribution | US and Argentina, Switzerland, Australia, Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany, Malaysia, Portugal, Netherlands, Singapore, and England |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052265 | SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL Smith & Nephew, Inc., Dec 27, 2005 |