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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 June 09, 2009
Date Posted August 04, 2009
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-1703-2009
Recall Event ID 52289
PMA Number P000013 
Product Classification hip prosthesis surgical procedure - Product Code MRA
Product Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55.
Code Information Literature Number LSP55, all units, no lot number.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall		 The Surgical Protocol has been modified to create separate and distinct surgical protocols, one for the Trident¿ PSL Shell (LSP68) and one for the Trident¿ Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique.
FDA Determined
Cause 2		 Labeling design
Action Stryker sent Urgent - Product Correction - Surgical Protocol letters by Federal Express on June 9, 2009 to all Stryker branches/agencies, hospital Risk Management, hospital Chief of Orthopaedics, surgeons and all foreign consignees.
Quantity in Commerce 2376 in USA, 1326 internationally
Distribution Worldwide 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.
PMA Database PMAs with Product Code = MRA and Original Applicant = HOWMEDICA OSTEONICS CORP.
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