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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 07, 2003
Date Posted February 27, 2003
Recall Status1 Terminated 3 on July 31, 2003
Recall Number Z-0587-03
Recall Event ID 25460
510(K)Number K952970  
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
Product Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, stem and condyle components. Also proximal tibial body rotating hinge-type knee and stem components.
Code Information Catalog No. Lot No. Description  6485-3-000 D6MR MRS SML FEM STEM 10 X 102; 6485-3-011 D6CEB MRS 11MM X 127MM FEMORAL STEM; 6485-3-013 D6CFB MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6CFG MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6CFE MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6GZE MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6GZC MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6HAB MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6HAC MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6HAD MRS 13MM X 127MM FEMORAL STEM; 6485-3-015 D6CHD MRS 15MM X 127MM FEMORAL STEM; 6485-3-017 D6BZC MRS 17MM X 127MM FEMORAL STEM; 6485-3-017 D6GPA MRS 17MM X 127MM FEMORAL STEM; 6485-3-017 D6GPD MRS 17MM X 127MM FEMORAL STEM; 6485-3-311 D6CAB MRS 11MM X 203MM FEMORAL STEM; 6485-3-311 D6CAA MRS 11MM X 203MM FEMORAL STEM; 6485-3-311 D6GTA MRS 11MM X 203MM FEMORAL STEM; 6485-3-311 D6GTB MRS 11MM X 203MM FEMORAL STEM; 6485-3-313 D6CBC MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6CBD MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6CBB MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6GWB MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6GWC MRS 13MM X 203MM FEMORAL STEM; 6485-3-317 D6GM MRS 17MM X 203MM FEMORAL STEM; 6485-6-409 D6HMA MRS 9MM TIBIAL STEM; 6485-6-411 D5XWB MRS 11MM TIBIAL STEM; 6485-6-411 D6HNA MRS 11MM TIBIAL STEM; 
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics
300 Commerce Court
Mahwah NJ 07430
For Additional Information Contact Tom Grzeskowiak
201-831-5495
Manufacturer Reason
for Recall		 Some components have disassociated post-operatively resulting in additional surgery to the patient.
FDA Determined
Cause 2		 Other
Action Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled devices.
Quantity in Commerce 136
Distribution The devices were distributed nationwide to Howmedica branches/agents, hospitals, one government hospital and internationally.
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 = JDI and Original Applicant = HOWMEDICA CORP.
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