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U.S. Department of Health and Human Services

Class 2 Device Recall Trident

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 Class 2 Recall
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Date Posted August 04, 2009
Recall Status1 Open
Recall Number Z-1703-2009
Recall Event ID 52289
Premarket Approval
PMA Number
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented - 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/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430
For Additional Information Contact Colleen O'Meara
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MRA and Applicant = HOWMEDICA OSTEONICS CORP.