JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422244, QTY: (1), STERILE EO, SMITH &
FDA device recall Z-0937-2010 · posted 2010-03-03 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HSX
- Quantity affected
- 737 units
- Distribution
- US and Argentina, Switzerland, Australia, Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany, Malaysia, Portugal, Netherlands, Singapore, and England
- Date initiated
- 2009-01-23
- Date posted
- 2010-03-03
- Date terminated
- 2011-03-25
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL (K052265) | Smith & Nephew, Inc. | 2005-12-27 |