| Class 2 Device Recall JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, | |
Date Initiated by Firm | January 23, 2009 |
Date Posted | March 03, 2010 |
Recall Status1 |
Terminated 3 on March 25, 2011 |
Recall Number | Z-0926-2010 |
Recall Event ID |
54269 |
510(K)Number | K052265 |
Product Classification |
Knee implant - Product Code HSX
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Product | JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 46MM, M/L 27 MM, REF 71422223, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116 |
Code Information |
All Lot Numbers |
Recalling Firm/ Manufacturer |
Smith & Nephew Inc 1450 E. Brooks Rd Memphis TN 38116
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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 | 1283 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 |
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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.
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510(K) Database | 510(K)s with Product Code = HSX
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