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 |
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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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510(K) Database | 510(K)s with Product Code = MEH
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