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U.S. Department of Health and Human Services

Class 2 Device Recall Crossfire

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  Class 2 Device Recall Crossfire see related information
Date Initiated by Firm January 09, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on March 08, 2004
Recall Number Z-0560-04
Recall Event ID 28181
Product Classification Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) - Product Code JDL
Product Crossfire Acetabular II Insert. Catalog No: 2041C-2642.
Code Information Lot 48921601
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics
300 Commerce Ct
Mahwah NJ 07430-2104
For Additional Information Contact Dominick Cristofolo
201-831-5247
Manufacturer Reason
for Recall		 This device is not approved for sale in the US.
FDA Determined
Cause 2		 Other
Action Letters dated 1/9/2004 and 1/12/2004 were sent to Surgical Resources and Dr. Vorenkamp alerting them to the situation.
Quantity in Commerce 3 (1 unit in US)
Distribution The one device was shipped to Surgical Resources, 1150 Torrey Road, Suite A, Fenton, MI 48430 for Dr. Steven E. Vorenkamp, M.D., Petoskey, MI..
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.
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