Date Initiated by Firm | February 17, 2006 |
Date Posted | March 02, 2010 |
Recall Status1 |
Terminated 3 on March 03, 2010 |
Recall Number | Z-0910-2010 |
Recall Event ID |
50150 |
510(K)Number | K031729 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | Triathlon X3 UHMWPE Tibial Inserts and Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ.
Intended to be used with femoral components in primary or revision total knee arthroplasty. |
Code Information |
Lot Numbers: 36325001; 36325102;36325302; 36325402; 36325602; 36326002; 36326201;33936308; 36605501; 36326601; 33934303; 33934705; 36327201; 36327301; 36327401; 36328101; 35453302; 36378501; 36604001; 36379001; 36379101; 36379201; 36379301; 36379401; 36604301; 36379501; 36604502; 36379901; 36326301; 36380001; 36380101; 35728201; 36380401; 36380601; 36380901; 36381201; 36381401; 35730101; 36381601; 35730602; 35921201; 35921301; 36382001; 35730801; 35730802; 35730803 and 36382101. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430
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For Additional Information Contact | Karen Ariemma, RAC 201-831-5718 |
Manufacturer Reason for Recall | Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts. |
FDA Determined Cause 2 | Process design |
Action | Stryker Orthopaedics issued an "Important Market Withdrawal" notification dated February 17, 2007 via federal express. Consignees were informed of the affected product and asked to retrieve, reconcile and return product via Return Material Authorization to the firm.
For further information, contact Stryker Orthopaedics Quality Assurance at 1-201-831-5825. |
Quantity in Commerce | 594 units total - all products. |
Distribution | Worldwide Distribution -- United States and Canada. |
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 = JWH
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