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U.S. Department of Health and Human Services

Class 2 Device Recall Eius Unicompartmental Knee System

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  Class 2 Device Recall Eius Unicompartmental Knee System see related information
Date Initiated by Firm August 17, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on March 26, 2014
Recall Number Z-0606-2012
Recall Event ID 60626
510(K)Number K052917  
Product Classification Prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymer - Product Code NPJ
Product Eius Unicompartmental Knee System
Stryker Howmedica Osteonics Corp.
Howmedica International S. de R.L., Raheen Business Park, Limerick, Ireland.

Intended for use in Unicompartmental Knee Arthroplasty (UKA). Surgeon users have identified the following potential advantages of UKA procedures versus Total Knee Arthroplasty procedures generally: conservation of the opposite compartment, preservation of ligaments and patellofemoral articulation, reduced loss of bone stock and lower implant cost. The EIUS UKA is a Resurfacing device that requires the removal of a thin condylar cross-section intended to replace the diseased cartilage only. This allows the surgeon to conserve good quality subchondral bone.
Code Information K052917, K9922887 6636-2-001 002,003, 004, 005, 011, 012, 013, 014, 015, 308, 309, 310, 312, 318, 319, 320, 322, 408, 409, 410, 412, 418, 419, 420, 422, 508, 509, 510, 512, 518, 519, 520, 522, 608, 609, 610, 612, 618, 619, 620, 622, 708, 709, 710, 712, 718, 719, 720, and 722 - ALL LOTS
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Ms. Colleen O'Meara
Manufacturer Reason
for Recall
Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices.
FDA Determined
Cause 2
Action Stryker Orthopaedics sent "URGENT PRODUCT RECALL" letters dated August 17, 18 and 25, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an attached Product Recall Acknowledgement Form via fax to 201-831-6069. Contact the firm at 201-972-2100 for questions concerning this recall.
Quantity in Commerce 26,648 units
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 = NPJ and Original Applicant = HOWMEDICA OSTEONICS CORP