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U.S. Department of Health and Human Services

Class 2 Device Recall Super SecurFit

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  Class 2 Device Recall Super SecurFit see related information
Date Initiated by Firm January 14, 2009
Date Posted December 22, 2009
Recall Status1 Terminated 3 on July 18, 2012
Recall Number Z-0557-2010
Recall Event ID 51180
510(K)Number K020615  
Product Classification hip prosthesis - Product Code MEH
Product Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile;
Arc Deposited, V40 taper
Not for use with 16mm heads.
Code Information Catalog Number: J6054-XXXX; All lots codes with an expiry prior to Aug. 2013.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Karen Ariemma
201-831-5000
Manufacturer Reason
for Recall		 Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.
FDA Determined
Cause 2		 Device Design
Action Stryker sent Urgent product Correction Letters on January 14, 2009 by Federal Express to Stryker branches/agencies, hospital risk management, chief of orthopaedics and surgeon.
Quantity in Commerce 786 total stems
Distribution Nationwide. Product was distributed to 3 Stryker branches/agencies and 2 hospitals in PA and CA.
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 = MEH and Original Applicant = HOWMEDICA OSTEONICS CORP.
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