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U.S. Department of Health and Human Services

Class 2 Device Recall Accolade Distal Spacer

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  Class 2 Device Recall Accolade Distal Spacer see related information
Date Initiated by Firm March 31, 2010
Date Posted May 12, 2010
Recall Status1 Terminated 3 on July 09, 2010
Recall Number Z-1593-2010
Recall Event ID 55213
510(K)Number K974054  
Product Classification orthopedic prosthesis component - Product Code JDI
Product Stryker Orthopaedics, Accolade Distal Centralizer 14 mm Large; Catalog No.: 1059-6714. For use with Accolade hip prosthesis.
Code Information Catalog No.: 1059-6714 Lot Code: WDYMLE
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Richard Wolyn
201-972-2100
Manufacturer Reason
for Recall		 One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers and size 13 Medium centralizers have been labeled as size 14 Large centraliizers.
FDA Determined
Cause 2		 Process control
Action Notification letters and Product Accountability Forms have been sent to Stryker Orthopaedics Branch and Agencies via Fed Ex on March 31, 2010 with return receipt.. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons were sent notificatio letters and Product Recall Acknowledgment Forms on April 1, 2010. with return reciept.
Quantity in Commerce 17
Distribution Nationwide distribution.
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, INC.
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