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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 June 01, 2003
Date Posted July 29, 2003
Recall Status1 Terminated 3 on November 13, 2003
Recall Number Z-0921-03
Recall Event ID 26415
510(K)Number K912190  
Product Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000.
Code Information lot 03030232.
Recalling Firm/
Stryker Instruments, Instruments Div.
4100 E. Milham
Kalamazoo MI 49001
For Additional Information Contact Dannielle Wheeler
800-800-4236 Ext. 7666
Manufacturer Reason
for Recall
Non-sterilized product sold as sterile.
FDA Determined
Cause 2
Action Sales representatives were notified on June 1, 2003 and requested to contact their accounts to determine if any product remained on the shelf. Recall letters dated June 12, 2003 were sent to each customer''s risk manager, surgical director and hospital administrator via certified mail
Quantity in Commerce 440 boxes
Distribution United States, Canada, Italy, Japan and United Kingdom

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 = and Original Applicant = STRYKER CORP.