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U.S. Department of Health and Human Services

Class 2 Device Recall TRI PRESSFIT STEM

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  Class 2 Device Recall TRI PRESSFIT STEM see related information
Date Initiated by Firm November 13, 2008
Date Posting Updated January 26, 2009
Recall Status1 Terminated 3 on January 20, 2010
Recall Number Z-0890-2009
Recall Event ID 50485
510(K)Number K070095  
Product Classification prosthesis, hip - Product Code JWH
Product Triathlon-Press-Fit Stem

These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee arthroplasty.
Code Information 5565-S-015 TRI PRESS-FIT STEM 15MM X 100MM M3M07B,, 5565-S-016 TRI PRESS-FIT STEM 16MM X 100MM M3M01B,, 5565-S-016 TRI PRESS-FIT STEM 16MM X 100MM M3M01E,, 5565-S-017 TRI PRESS-FIT STEM 17MM X 100MM M3M03A,, 5566-S-012 TRI PRESS-FIT STEM 12X150MM M3L11F,, 5566-S-013 TRI PRESS-FIT STEM 13X150MM M3L12B,, and , 5566-S-018 TRI PRESS-FIT STEM 18X150MM M3L17D.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Karen Ariemma, RAC
201-831-5000
Manufacturer Reason
for Recall
Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.
FDA Determined
Cause 2
Packaging
Action Recall notification letters were sent via Federal Express on November 21, 2008 to Stryker Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeon. The letters explained the problem and indicated that there are no risk factors. Contact Stryker Orthopaedics for additional information at 1-201-831-5718.
Quantity in Commerce 322 total units - all types
Distribution Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
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 = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP
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