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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, see related information
Date Initiated by Firm January 23, 2009
Date Posted March 03, 2010
Recall Status1 Terminated 3 on March 25, 2011
Recall Number Z-0958-2010
Recall Event ID 54269
510(K)Number K052265  
Product Classification Knee implant - Product Code HSX
Product JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933296, 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 Contact David 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
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 in Commerce 60 units
Distribution US and Argentina, Switzerland, Australia, Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany, Malaysia, Portugal, Netherlands, Singapore, and England
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HSX and Original Applicant = SMITH & NEPHEW, INC.
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