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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-0556-2010
Recall Event ID 51180
510(K)Number K020615  
Product Classification hip prosthesis - Product Code MEH
Product Stryker Howmedica Osteonics, Super SecurFit HA Hip Stem; Sterile
Arc Deposited, V40 taper
Not for use with 16mm heads.
Code Information Catalog numbers: J6051-0425, J0651-0525, J6051-0625. All lot codes with an expiry prior to Aug. 2013.
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Karen Ariemma
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.