Restoration HA Reduced Neck 255 mm Long Stem Manufactured by Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The Restoration HA cementless Hip System is designed to address the problems of revision surgery where extensive fixation both distally and proximally is required for support of the prosthesis. A comprehensive size range mates a variety of proximal cross sections and lengths with 10 distal cylindrical diameters to provide for patient matched sizing in revision circumstances. The stem design incorporates a physiologic 127 degree neck stem angle, neck length ranges and a C-Taper head to provide the surgeon with the ability to restore near anatomic head position for proper leg length and biomechanical function. Restoration HA femoral component accepts C-Taper heads, 22mm, 26mm, 28mm, and 32mm with a negative 5mm to positive 10mm offsets.
FDA Recall Z-1677-2012 · Posted 2012-05-29
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMEH
Date Initiated2011-10-27
Date Terminated2013-08-22
Product Quantity31 Units
Reason for Recall
An incorrect laser mark was noted on specific lots of product, incorrectly implying a stem size of 9, when the product is actually size 8.
Firm Action
Stryker sent an "URGENT PRODUCT RECALL" letter dated October 27, 2011 and October 28, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs the customers to return the product to the firm. An Acknowledgement Form was included for customers to complete and return. Contact the firm at 201-972-2100 for questions regarding this recall.
Root Cause
Error in labeling
Distribution Pattern
Nationwide Distribution and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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