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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics

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  Class 2 Device Recall Stryker Orthopaedics see related information
Date Initiated by Firm June 25, 2015
Date Posting Updated September 23, 2015
Recall Status1 Terminated 3 on August 30, 2017
Recall Number Z-2810-2015
Recall Event ID 71754
510(K)Number K033716  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Trident 10 degrees X3 Insert 36 mm ID
Catalog #623-10-36I
Hip implant component
Code Information Lot Code 3Y0KHP
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Ms. Aminah Crawford
201-831-5000
Manufacturer Reason
for Recall
it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Stryker Orthopaedics notified their branches via email on 6/25/2015. Notification letters and Product Accountability Forms were mailed to Stryker Branches/Agencies on 817/2015 and hospital risk management on 8/18/2015.
Quantity in Commerce 16 units
Distribution Distributed in WI.
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 = LPH and Original Applicant = HOWMEDICA OSTEONICS CORP
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