Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERALsee related information
Date Initiated by FirmJanuary 23, 2009
Date PostedMarch 03, 2010
Recall Status1 Terminated 3 on March 25, 2011
Recall NumberZ-0949-2010
Recall Event ID 54269
510(K)NumberK052265 
Product Classification Knee implant - Product Code HSX
ProductJOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422258, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116
Code Information All Lot Numbers
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information ContactDavid Archer
901-399-5427
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionAll 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 Commerce849 units
DistributionUS and Argentina, Switzerland, Australia, Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany, Malaysia, Portugal, Netherlands, Singapore, and England
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HSX
-
-