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U.S. Department of Health and Human Services

Class 2 Device Recall Trident

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  Class 2 Device Recall Trident see related information
Date Initiated by Firm January 21, 2008
Date Posted June 12, 2008
Recall Status1 Terminated 3 on September 25, 2012
Recall Number Z-1172-2008
Recall Event ID 46691
510(K)Number K013676  
Product Classification hip prosthesis acetabular component - Product Code MEH
Product Trident Hemispherical Multi
Arc Deposited;
Hydroxylapatite Coated; Multiholed; Use with Size A insert;
hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430
Code Information Catalog Numbers: 500-11-42A; 508-11-4B; 508-11-46C; 508-11-48D; 508-11-50D; 508-11-52E; 508-11-54E; 508-11-56F; 508-11-58F; 508-11-60G; 508-11-62G; 50811-64H; 508-11-66H; 508-11-68I; 508-11-70I; 598-11-72J; 508-11-74J. All lot codes with expiration dates of 1/2005 and 12/2012.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Ms. Colleen O'Meara
201-831-5000
Manufacturer Reason
for Recall		 Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.
FDA Determined
Cause 2		 Process design
Action Recall notification letters were sent to Stryker Branches/agencies, OR Supervisors and Chief of Orthopaedics on 1/21/08. A Patient information sheet was sent on 2/4/08 to surgeons and hospitals. Per call with Center 2/4/08, recall letter to be revised and RES updated upon receipt. The letter was revised and sent on February 28, 2008 to include Trident PSL Acetabular shells. This letter was sent to Risk Management at hospitals and included the scope of the recall , the potential hazard and recommendation to physicians to monitor patients consistent with care for those receiving total hip replacement. It was also sent to surgeons and a revised letter to Stryker branches. A product acknowledgement form was included in all letters to indicate receipt of letter and quantity of product on hand, if applicable.
Quantity in Commerce 129,312 total shells, all Trident Hemispherical types
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 = MEH and Original Applicant = HOWMEDICA OSTEONICS CORP.
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